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Results for “OPHTHALMIC SOLUTIONS”

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At least 73 records · Page 4Linked to original sources

PubMed2006

Ocular hypotensive efficacy and safety of brinzolamide ophthalmic suspension 1% added to travoprost ophthalmic solution 0.004% therapy in patients with open-angle glaucoma or ocular hypertension.

OBJECTIVE: The primary objective of this study was to determine if combined travoprost ophthalmic solution 0.004% and brinzolamide ophthalmic suspension 1% therapy is superior in lowering intraocular pressure (IOP) compared to travoprost monotherapy for patients with open angle glaucoma or ocular hypertension. The secondary objective was to measure the percentage of patients achieving IOP levels of 18 mmHg or less. STUDY DESIGN AND METHODS: Single arm, open-label. PARTICIPANTS: eighty-two patients with inadequate IOP control with travoprost monotherapy. INTERVENTION: the addition of brinzolamide ophthalmic suspension 1% twice daily. MAIN OUTCOME MEASURES: The primary endpoint was mean IOP reduction from baseline at 4 and 12 weeks. The percentage of patients who achieved IOP values <or= 18 mmHg was also measured. RESULTS: The mean age of the patients was 67 years. Ethnic origin was 92.7% Caucasian, 3.7% Black, 2.4% Asian and 1.2% other. The mean duration of travoprost treatment before the trial started was 30 weeks. Compared to the baseline data (IOP = 22.5 mmHg) with travoprost ophthalmic solution 0.004% monotherapy, IOP was decreased after 4 (n = 78) and 12 (n = 71) weeks of combined travoprost and brinzolamide therapy by an average of 3.9 mmHg (17.4%) and 4.2 mmHg (18.4%), respectively. At baseline 6.3% of patients had an IOP of 18 mmHg or less whereas at 4 and 12 weeks, 53.8% and 60.6% of patients respectively had an IOP of 18 mmHg or less. Common adverse events were mild and included ocular hyperaemia, dysgeusia and eye irritation. STUDY LIMITATIONS: this study had a small sample size and was open-label. CONCLUSION: Patients receiving combined travoprost ophthalmic solution 0.004% and brinzolamide ophthalmic suspension 1% therapy had lower IOP values compared to those on travoprost monotherapy (p < 0.0001). Combined therapy resulted in a significantly greater percentage of patients achieving IOPs of 18 mmHg or less (p < 0.0001).

Adult↗

PubMedDate not supplied

A case of cystoid macular edema associated with latanoprost ophthalmic solution.

BACKGROUND: Although there have been reports of adverse effects after use, it is unclear whether latanoprost ophthalmic solution contributes to the development of cystoid macular edema (CME). CASE: A 71-year-old man underwent lens extraction, the insertion of an intraocular lens, and vitrectomy for elevated intraocular pressure (IOP) associated with lens subluxation in the left eye. After the surgery, antiglaucoma ophthalmic solutions controlled IOP well for over a year, maintaining good visual acuity with no abnormalities in the fundus. OBSERVATIONS: Two months after the previously prescribed antiglaucoma ophthalmic solutions were replaced by latanoprost, the patient's visual acuity decreased and CME developed. When latanoprost was replaced by other antiglaucoma ophthalmic solutions for controlling IOP, CME disappeared and visual acuity returned to the base level. CONCLUSIONS: Latanoprost may be involved in the development of CME. Patients who have undergone vitreous surgery or those with aphakia should be carefully observed for the possible development of CME associated with the use of latanoprost, even a long time after surgery.

Aged↗

PubMed2002

[Antibiotic ophthalmic solutions evaluated by pharmacokinetic parameters of maximum concentration in the aqueous].

PURPOSE: In order to determine whether the one-component method for calculating drug concentration in the aqueous(AQCmax) is useful for selecting an appropriate ophthalmic solution, 6 general purpose antimicrobial ophthalmic solutions already on the market were investigated. METHODS: The drugs examined were levofloxacin (LVFX), chloramphenicol(CP), erythromycin lactobionate(EM), micronomicin sulfate(MCR), cefmenoxime hydrochloride(CMX) and disodium sufobenzyl penicillin(SBPC). Fifty microliters of each solutions was instilled into the cul-de-sac of New Zealand White rabbit eyes 3 times at 15-minute intervals. The drug concentrations in(the anterior sac aqueous,: this is wrong) the aqueous humor 10, 30, 60, 120 and 240 minutes after the final instillation were examined by high performance liquid chromatography(HPLC) and/or bioassay. The AQCmax was calculated using the one-compartment method. RESULTS: The calculated AQCmax was 2.5 micrograms/ml (HPLC method) and 2.28 micrograms/ml (Bioassay Method) for LVFX, 2.17 micrograms/ml for CP, and 0.45 microgram/ml for EM. The AQCmax for CMX, MCR and SBPC could not be calculated by the one-compartment method. CONCLUSION: The AQCmax of LVFX was higher than that of the 2 other general purpose antimicrobial ophthalmic solutions. The AQCmax of these drugs might be a useful parameter for selecting an appropriate ophthalmic solution for the treatment of infected eyes.

Aminoglycosides↗

PubMed2005

The safety and efficacy of travoprost 0.004%/timolol 0.5% fixed combination ophthalmic solution.

PURPOSE: To compare the safety and intraocular pressure (IOP)-lowering efficacy of travoprost 0.004%/timolol 0.5% fixed combination ophthalmic solution (Trav/Tim) to its components travoprost 0.004% ophthalmic solution, TRAVATAN, (Trav) and timolol 0.5% ophthalmic solution (Tim) in patients with open-angle glaucoma or ocular hypertension. DESIGN: Randomized multicenter, double-masked, active-controlled, parallel group study. METHODS: Two hundred sixty-three patients with open-angle glaucoma or ocular hypertension were randomized to receive Trav/Tim once daily AM (and vehicle PM), Trav once daily PM (and vehicle AM), or Tim twice daily (AM and PM). Efficacy and safety were compared across treatment groups over 3 months. RESULTS: Trav/Tim produced a mean IOP decrease from baseline of 1.9 mm Hg to 3.3 mm Hg more than Tim, with a significant decrease in mean IOP at each of the nine study visits (P < or = .003). Trav/Tim decreased mean IOP by 0.9 mm Hg to 2.4 mm Hg more than Trav, with a significant decrease in mean IOP at seven of the nine study visits (P < or = .05). The adverse event profile for Trav/Tim was comparable to Trav or Tim alone. CONCLUSIONS: Over the 3 months of treatment, Trav/Tim produced clinically relevant IOP reductions in patients with open-angle glaucoma or ocular hypertension that were greater than those produced by either Trav or Tim alone. The clinical results that Trav/Tim was safe and well tolerated with an incidence of adverse events was comparable to the results of Trav or Tim alone. Trav/Tim provides both more effective IOP reduction than its components and the benefits of once-daily dosing.

Adult↗

PubMedDate not supplied

General purpose antimicrobial ophthalmic solutions evaluated using new pharmacokinetic parameter of maximum drug concentration in aqueous.

PURPOSE: In order to determine whether the one-component method for calculating drug concentration in the aqueous (AQC(max)) is useful for selecting an appropriate ophthalmic solution, six general purpose antimicrobial ophthalmic solutions already on the market were investigated. METHODS: The drugs examined were levofloxacin (LVFX), chloramphenicol (CP), erythromycin lactobionate (EM), micronomicin sulfate (MCR), cefmenoxime hydrochloride (CMX), and disodium sulfobenzyl penicillin (SBPC). Fifty microliters of each solution was instilled into the cul-de-sac of New Zealand White rabbit eyes three times at 15-minute intervals. The drug concentrations in the aqueous humor 10, 30, 60, 120, and 240 minutes after the final instillation were examined by high performance liquid chromatography (HPLC) and/or bioassay. The AQC(max) was calculated using the one-compartment method. RESULTS: The calculated AQC(max) was 2.5 microg/mL (HPLC method) and 2.28 microg/mL (bioassay method) for LVFX, 2.17 microg/mL for CP, and 0.45 microg/mL for EM. The AQC(max) for CMX, MCR, and SBPC could not be calculated by the one-compartment method. CONCLUSIONS: The AQC(max) of LVFX was higher than that of the two other general purpose antimicrobial ophthalmic solutions. The AQC(max) of these drugs might be a useful parameter for selecting an appropriate ophthalmic solution for the treatment of infected eyes.

Animals↗

PubMed2005

Aqueous penetration and biological activity of moxifloxacin 0.5% ophthalmic solution and gatifloxacin 0.3% solution in cataract surgery patients.

PURPOSE: To measure the achievable perioperative aqueous concentration of the commercially available topically administered fourth generation fluoroquinolones, moxifloxacin 0.5% ophthalmic solution, and gatifloxacin 0.3% ophthalmic solution, and to correlate this concentration with the agents' biological efficacy in the aqueous humor of patients undergoing routine cataract surgery. DESIGN: Prospective, randomized, parallel, double-masked, clinical trial. PARTICIPANTS: Fifty patients undergoing cataract extraction. METHODS: Patients (n = 25) were given perioperative topical moxifloxacin 0.5% or topical gatifloxacin 0.3% (n = 25). One drop of antibiotic was administered every 10 minutes for 4 doses beginning 1 hour prior to surgery. Aqueous humor was sampled via paracentesis and antibiotic concentrations were determined using validated high performance liquid chromatography (HPLC) procedures. Dilution analyses were performed to determine the biological efficacy of the agents in the aqueous against Staphylococcus epidermidis, the most common cause of postcataract endophthalmitis. MAIN OUTCOME MEASURES: Aqueous humor antibiotic concentrations were measured using HPLC and microdilution bioassay techniques. Biological activity was measured as minimal inhibitory dilution and minimal bactericidal dilution. RESULTS: Aqueous humor concentrations for moxifloxacin via HPLC analysis were 1.80 (+/-1.21) microg/ml, whereas those for gatifloxacin were 0.48 (+/-0.34) microg/ml. This 3.8-fold difference in aqueous humor antibiotic concentrations was statistically significant (P = 0.00003). Similarly, the biological dilution analysis of the aqueous humor samples showed that moxifloxacin attained an estimated activity of 2.1 microg/ml, whereas the gatifloxacin activity was approximately 0.4 mug/ml, which represented a 4.9-fold difference. CONCLUSIONS: This study demonstrated that after topically administered perioperative antibiotics with cataract surgery, moxifloxacin 0.5% ophthalmic solution achieved a statistically significantly higher concentration in aqueous humor compared with gatifloxacin (P = 0.00003). Results from the broth dilution analysis showed that moxifloxacin 0.5% was biologically more active against S. epidermidis than gatifloxacin 0.3% in aqueous humor after topical application. There were no adverse events reported, and incision wounds healed quickly and as expected.

Administration, Topical↗

PubMedDate not supplied

A comparison of morning and evening instillation of a combination travoprost 0.004%/timolol 0.5% ophthalmic solution.

PURPOSE: To compare the intraocular pressure lowering efficacy and side effect profile of travoprost 0.004%/timolol 0.5% ophthalmic solution dosed in the morning and evening. METHODS: This was a multicenter, prospective, randomized, double-masked, parallel group clinical study of 92 patients with open-angle glaucoma (with or without pseudoexfoliative or pigmentary glaucoma) or ocular hypertension. After a washout of existing glaucoma medications, patients were randomly assigned to receive one drop of travoprost 0.004%/timolol 0.5% in the morning or evening for 6 weeks. The main outcome measures were mean intraocular pressure (IOP) assessed at 9 am, 11 am, and 4 pm, and safety variables. RESULTS: Travoprost 0.004%/timolol 0.5% ophthalmic solution, dosed in the morning or evening, controlled IOP consistently throughout the day. Mean IOP ranged from 16.5 to 16.7 mmHg in the morning treatment group and from 16.1 to 17.2 mmHg in the evening treatment group. Travoprost 0.004%/timolol 0.5% ophthalmic solution produced statistically significant and clinically relevant reductions in IOP from baseline; mean reductions ranged from approximately 8 to 10 mmHg (32% to 38%). Travoprost 0.004%/timolol 0.5% ophthalmic solution was safe and well tolerated with the most frequently reported adverse event being ocular hyperemia, which occurred in 12.5% of patients in the morning treatment group and 13.6% of patients in the evening treatment group. CONCLUSIONS: Travoprost 0.004%/timolol 0.5% given once daily, either in the morning or evening, is a safe and effective treatment for open-angle glaucoma and ocular hypertension. It may be beneficial for patients judged to be inadequately controlled on a prostaglandin analogue or ophthalmic beta-blocker alone.

Adult↗

PubMed2003

[Effectiveness and impact in the quality of life of ketotifen ophthalmic solution. Results of zeta study in patients with seasonal allergic conjunctivitis].

PURPOSE: To study the effectiveness of ketotifen ophthalmic solution (0.25 mg/ml) in seasonal allergic conjunctivitis (SAC) and the impact on the patient's quality of life. METHODS: A multicentric, longitudinal, prospective study was designed. 284 Spanish ophthalmologists participated recruiting 1145 patients with SAC. After obtaining the informed consent, a drop of ketotifen ophthalmic solution was instilled. At the visit, clinical symptoms pre and post-treatment were assessed. The patients answered a questionnaire of quality of life (QOL) pre-treatment and minimum one week after initiating the treatment. The qualitative variables were described by the percentage, and the quantitative were described by the average, median, standard deviation, and maximum and minimum values. The effectiveness (change of intensity of the symptoms) and the quality of life were studied by the Wilcoxon test with a significance level of 5% (alpha = 0.05). RESULTS: Following the instillation of the ketotifen ophthalmic solution the intensity of the ocular symptoms (redness, edema, tearing, secretion, photophobia and visual acuity impairment) decreased significantly. Comparing both QOL, we observed a statistically significant reduction of the limitation perceived by the patients in their daily activities, animic state and ocular symptoms. In 0,7% some adverse event was referred, none was serious and only in one case the probable relationship with the drug was specified. CONCLUSION: The results of the ZETA study demonstrate the tolerability and effectiveness of the ketotifen ophthalmic solution for all the symptoms of SAC in clinical practice, observing improvement in the quality of life of the patient.

Adolescent↗

PubMed2004

Clinical efficacy of olopatadine vs epinastine ophthalmic solution in the conjunctival allergen challenge model.

BACKGROUND: Olopatadine hydrochloride 0.1% ophthalmic solution (Patanol) and epinastine hydrochloride 0.05% ophthalmic solution (Elestat) are two topical antiallergic agents. Olopatadine is indicated for the treatment of the signs and symptoms of allergic conjunctivitis that include itching, redness, tearing, lid swelling, and chemosis. Epinastine is indicated for the prevention of itching associated with allergic conjunctivitis. OBJECTIVE: This study compared the clinical efficacy of olopatadine and epinastine in the prevention of itching and conjunctival redness in the conjunctival allergen challenge (CAC) model. RESEARCH DESIGN AND METHODS: This was a prospective, randomized, double-masked, contralaterally-controlled, single center allergen challenge study. Ninety-six subjects with a history of allergic conjunctivitis were screened, and the 66 who responded to conjunctival allergen challenge at visits 1 and 2 were randomized into 1 of 3 treatment groups at visit 3 to receive one drop of study medication in each eye: (1) olopatadine in one eye and epinastine in the fellow eye, (2) olopatadine in one eye and placebo in the fellow eye, and (3) epinastine in one eye and placebo in the fellow eye. Five minutes after study drop instillation, subjects were bilaterally challenged with the allergen concentration that had elicited a positive conjunctival allergic response at Visits 1 and 2. Subjective itching assessments were given at 3 min, 5 min, and 7 min post challenge. Objective redness and chemosis assessments were made at 10 min, 15 min, and 20 min post challenge. Paired sample two-tailed t-tests were performed on the mean scores at each time point to assess statistical significance in the differences between treatments. MAIN OUTCOME MEASURES; RESULTS: Fifty-three subjects were randomized into the olopatadine/epinastine treatment group, the primary analysis group. Olopatadine treated eyes exhibited significantly lower mean itching and conjunctival redness scores than the contralateral epinastine treated eyes, -0.19 (p = 0.003) and -0.52 (p < 0.001), respectively. Olopatadine treated eyes also exhibited significantly less chemosis -0.24 (p < 0.001), ciliary redness -0.55 (p < 0.001), and episcleral redness -0.58 (p < 0.001) than epinastine treated eyes. CONCLUSION: Olopatadine is significantly more effective than epinastine in controlling itching, redness and chemosis associated with allergic conjunctivitis in the CAC model.

Administration, Topical↗

PubMed2004

Miotic effect of brimonidine tartrate 0.15% ophthalmic solution in normal eyes.

PURPOSE: To evaluate the effect of brimonidine tartrate 0.15% ophthalmic solution (Alphagan P) on pupil diameter in eyes of healthy adults under different luminance conditions. SETTING: Center for Refractive Surgery, Ophthalmology Service, Department of Surgery, Walter Reed Army Medical Center, Washington, DC, USA. METHODS: Using a Colvard pupillometer, the pupil diameter was measured in 15 eyes of 15 healthy adults under 3 luminance conditions (scotopic, mesopic, photopic). The luminance of the room was measured using the Minolta LS-110 Luminance Meter. Pupil diameter was remeasured using the same technique 30 minutes, 4 hours, and 6 hours after administration of 1 drop of brimonidine tartrate 0.15% ophthalmic solution. RESULTS: Under scotopic conditions (luminance 0.0 candelas [cd]/m(2)), the pupil diameter decreased by 1.0 mm or more in 100%, 87%, and 60% of eyes at 30 minutes, 4 hours, and 6 hours, respectively (P<.005); under mesopic conditions (luminance 0.2 cd/m(2)), in 93%, 73%, and 40% of eyes, respectively (P<.005); and under photopic conditions (luminance 150.2 cd/m(2)), in 73%, 87%, and 67% of eyes, respectively (P<.005). CONCLUSIONS: Brimonidine tartrate 0.15% ophthalmic solution produced a significant miotic effect under all 3 luminance conditions. The reproducible miotic effect under scotopic and mesopic conditions may help postoperative refractive patients who report night-vision difficulties related to a large pupil.

Adrenergic alpha-Agonists↗

PubMed1996

Inhibition of steroid-induced cataract in rat eyes by administration of vitamin-E ophthalmic solution.

The efficacy of a vitamin-E (VE) ophthalmic solution was evaluated on a newly developed rat steroid-induced cataract model. Brown Norway rats irradiated with 2 Gy X-ray, right eyes only, were divided into 5 groups: the control group; 2 steroid (1 mg/kg/day)-treated groups with topic (Top) and systemic (Sys) administration, and 2 VE-treated groups, 1 with the same treatment as the Top group with the addition of 5% VE twice a day (Top + VE) and 1 with the same treatment as the Sys group with 5% VE twice a day (SYS + VE). The lens changes were documented with a Scheimpflug camera and changes in light scattering were evaluated quantitatively. The VE-treated groups (Top + VE and Sys + VE) showed a significant inhibition of the increase in the opaque area compared with each of the non-VE-treated groups. The VE ophthalmic solution was strong enough to prevent steroid-induced cataract in rats.

Animals↗

PubMed1998

Comparative effects of ketorolac 0.5% or diclofenac 0.1% ophthalmic solutions on inflammation after cataract surgery.

OBJECTIVE: Ketorolac tromethamine 0.5% and diclofenac sodium 0.1% ophthalmic solutions are approved for use by the U.S. Food and Drug Administration to avoid excessive postoperative inflammation after cataract surgery and implantation of an intraocular lens. This study compares the efficacy and toxicity of these nonsteroidal anti-inflammatory drugs for the first time. DESIGN: Randomized, double-masked, prospective clinical trial. PARTICIPANTS: A total of 120 patients assigned in equal numbers to 1 of the 2 treatment regimens. INTERVENTION: Treatment with either ketorolac 0.5% or diclofenac 0.1% ophthalmic solutions instilled four times daily for 30 days beginning the first postoperative day after surgery. MAIN OUTCOME MEASURES: Objective (Kowa FC 1000 laser cell and flare meter) and subjective (slit-lamp biomicroscope) measurements of inflammation and toxicity were made and compared at three separate post-operative visits. RESULTS: The anti-inflammatory effects of the two treatment regimens were not statistically different at any of the postoperative visits. Patients tolerated both treatments equally well. CONCLUSIONS: This study shows diclofenac sodium 0.1% and ketorolac tromethamine 0.5% ophthalmic solutions are equally effective and safe for the control of postoperative inflammation after uncomplicated cataract surgery performed by phacoemulsification followed by the implantation of a foldable intraocular lens.

Aged↗

PubMed1994

Efficacy of lodoxamide 0.1% ophthalmic solution in resolving corneal epitheliopathy associated with vernal keratoconjunctivitis.

A multicenter, randomized, double-masked, parallel-group study compared the long-term efficacy and safety of lodoxamide 0.1% ophthalmic solution and placebo in 118 patients with vernal keratoconjunctivitis. The test drugs were instilled four times daily for 90 days. Lodoxamide 0.1% ophthalmic solution was significantly (P < .05) more effective than placebo in lowering severity scores for epithelial disease and corneal staining, evidence of the superior efficacy of lodoxamide 0.1% ophthalmic solution in reversing the corneal complications commonly associated with moderate to severe vernal keratoconjunctivitis. Additionally, lodoxamide 0.1% ophthalmic solution ameliorated the other key signs of vernal keratoconjunctivitis, including upper tarsal papillae, limbal signs (papillae, hyperemia, and Trantas' dots), and conjunctival discharge. The between-group differences in the relief of symptoms (itching, tearing, and photophobia) were clinically significant but not always statistically significant. Treatment-related adverse events were reported with similar frequency in both treatment groups, and none were serious.

Adolescent↗

PubMed2005

Clinical safety of moxifloxacin ophthalmic solution 0.5% (VIGAMOX) in pediatric and nonpediatric patients with bacterial conjunctivitis.

Five independent, multicentered, double-masked, parallel, controlled studies were conducted to determine the safety of moxifloxacin ophthalmic solution 0.5% (VIGAMOX) in pediatric and nonpediatric patients with bacterial conjunctivitis. Patients were randomized into one of two treatment groups in each study and received either moxifloxacin ophthalmic solution 0.5% b.i.d. or t.i.d. or a comparator. A total of 1,978 patients (918 pediatric and 1,060 nonpediatric) was evaluable for safety. The most frequent adverse event in the overall safety population was transient ocular discomfort, occurring at an incidence of 2.8%, which was similar to that observed with the vehicle. No treatment-related changes in ocular signs or visual acuity were observed with moxifloxacin ophthalmic solution 0.5%, except for one clinically relevant change in visual acuity. Thus, based upon a review of adverse events and an assessment of ocular parameters, moxifloxacin ophthalmic solution 0.5% formulated without the preservative, benzalkonium chloride, is safe and well tolerated in pediatric (3 days-17 years of age) and nonpediatric (18-93 years) patients with bacterial conjunctivitis.

Adult↗

PubMedDate not supplied

Evaluation of efficacy and safety of ciprofloxacin ophthalmic solution versus chloramphenicol.

The results of this clinical study demonstrate that ciprofloxacin ophthalmic solution 0.3% is as safe and as effective as 0.5% chloramphenicol ophthalmic solution in the treatment of conjunctivitis and blepharitis of bacterial aetiology. Both agents achieved microbiological improvement rates in excess of 90% after 1 week's treatment. On ciprofloxacin 93.5% of patients were judged clinically cured or improved versus 84.6% on chloramphenicol after 1 week. There were no serious adverse affects. One patient in each group suffered drug-related side-effects (chemosis, erythema) which resolved on discontinuation or changing of therapy. Cirpofloxacin is not associated with the rare, but serious, side effect of aplastic anaemia which is associated with chloramphenicol use. On the evidence of this study ciprofloxacin would appear to be an appropriate agent for general use as a topical ophthalmic formulation.

Acute Disease↗

PubMed1996

Extemporaneous preparation of antibiotic ophthalmic solutions.

Until the introduction of ocular ciprofloxacin, the standard of practice in treating bacterial corneal ulcers required topical antibiotic ophthalmic solutions that were either not commercially available or not available in the higher concentrations needed. A survey was mailed to 125 hospital pharmacies and 125 community pharmacies in Oklahoma to determine the availability of extemporaneously prepared antibiotic ophthalmic solutions. Of 72 hospital pharmacies and 60 community pharmacies that responded, 17 hospital and 2 community pharmacies reported that they do compound these solutions. The main reasons given by the other pharmacies for not offering this service were the lack of a laminar flow hood or other equipment and lack of an aseptic environment. If extemporaneously prepared antibiotic ophthalmic solutions are needed to treat corneal ulcers, then pharmacists have a responsibility to prepare them. The recent publication of a handbook providing formulations for those products and the "ASHP Technical Assistance Bulletin on Pharmacy-Prepared Ophthalmic Products" may encourage more pharmacies to provide this needed service.

Administration, Topical↗

PubMed2000

Incidence of postoperative posterior capsular opacification following treatment with diclofenac 0.1% and ketorolac 0.5% ophthalmic solutions: 3-year randomized, double-masked, prospective clinical investigation.

PURPOSE: Laboratory studies in experimental animals suggest that use of nonsteroidal anti-inflammatory drugs decreases the incidence of posterior capsular opacification (PCO) following cataract surgery. Recently the incidence of PCO following cataract surgery and intraocular lens implantation was reported to be no different following postoperative treatment with diclofenac sodium 0.1% (Voltaren, Ciba Vision) or with dexamethasone 0.1% (Maxidex, Alcon). We studied the incidence of PCO in patients following treatment with diclofenac 0.1% and ketorolac tromethamine 0.5% (Acular, Allergan) ophthalmic solutions 3 years after cataract surgery and implantation of a foldable silicone intraocular lens. METHODS: A total of 120 patients underwent phacoemulsification and implantation of a foldable silicone intracular lens. Patients were treated with either diclofenac 0.1% ophthalmic solution or 0.5% ketorolac ophthalmic solution 4 times daily for 30 days in a double-masked, randomized fashion during the postoperative period. Patients were examined 3 years following surgery by a masked observer who determined which patients received YAG capsulotomies and graded any existing PCO. RESULTS: Each treatment group had 12% YAG capsulotomies 3 years following surgery. Although PCO was present more often with diclofenac treatment (25/62) than with ketorolac treatment (16/58), this difference is not statistically significant (P = .142). Patients tolerated both treatments well without a difference in toxic effects or tolerability. CONCLUSIONS: This study did not demonstrate a difference in the ability of diclofenac or ketorolac ophthalmic solutions to prevent PCO following cataract extraction and implantation of an intraocular lens. Both treatment regimens were equally well tolerated.

Aged↗

PubMed2004

Safety and efficacy of ketorolac tromethamine 0.4% ophthalmic solution in post-photorefractive keratectomy patients.

PURPOSE: To evaluate the safety and analgesic efficacy of ketorolac tromethamine 0.4% ophthalmic solution in postoperative photorefractive keratectomy (PRK) patients. SETTING: Fifteen clinical sites in the eastern and southern United States. METHODS: This pooled analysis of 2 multicenter, randomized, double-masked, vehicle-controlled, parallel-group studies comprised 313 patients having unilateral PRK. After surgery, patients were treated with 1 drop of ketorolac tromethamine 0.4% ophthalmic solution (Acular(R) LS) (n = 156) or vehicle (n = 157) 4 times daily for up to 4 days. Pain intensity, pain relief, use of escape medication, and severity of ocular symptoms were assessed. Adverse events, epithelial healing, and visual acuity were recorded. RESULTS: There was significantly less pain intensity experienced by patients in the ketorolac group (P<.001). During the first 12 hours post PRK, 50% fewer patients in the ketorolac group than in the vehicle group had severe to intolerable pain (41.6% [64/154] and 84.5% [131/155], respectively). The median time to no pain was 30 hours in the ketorolac group and 54 hours in the vehicle group (P<.001, survival analysis). Ketorolac patients reported significantly greater pain relief than vehicle patients throughout the study (P<.001). Ketorolac patients used significantly less escape medication than vehicle patients for 48 hours post PRK (P< or =.008). Treatment-related adverse events occurred in 2.6% (4/156) of ketorolac patients and 6.4% (10/157) of vehicle patients. CONCLUSION: Ketorolac 0.4% ophthalmic solution is safe and effective in reducing ocular pain when used 4 times daily for up to 4 days post PRK.

Adolescent↗