SEARCH · PubMed Health

Results for “OPHTHALMIC SOLUTIONS”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 91 records · Page 5Linked to original sources

PubMed1999

Efficacy and safety of nonpreserved ketorolac ophthalmic solution in postoperative ocular pain following radial keratotomy.

PURPOSE: To investigate the efficacy and safety of nonpreserved ketorolac tromethamine 0.5% ophthalmic solution in relieving pain following radial keratotomy (RK). SETTING: Multicenter clinical trial. METHODS: Topical ketorolac was compared with its vehicle in a double-masked, randomized, parallel-group study involving 170 RK patients. Patients were treated with nonpreserved ketorolac 0.5% ophthalmic solution or the vehicle 4 times daily beginning immediately after surgery and continuing for 3 days or until they no longer had ocular pain. RESULTS: At several intervals, patients treated with ketorolac reported significantly greater pain relief and less pain intensity than patients treated with the vehicle. The time required for patients to first report "complete relief" or "no pain" was shorter in the ketorolac than in the vehicle group (P < or = .006). Patients in the ketorolac group used less escape medication (acetaminophen) (P < or = .001) and had fewer sleep difficulties (P < or = .031), fewer symptoms of ocular discomfort (P < or = .028), and less difficulty performing activities of daily living (P = .048). Patients treated with ketorolac experienced the same low rate of treatment-related adverse events as those treated with the vehicle and exhibited the same improvement in visual acuity and manifest refraction. CONCLUSIONS: Nonpreserved ketorolac tromethamine 0.5% ophthalmic solution was significantly more effective than, and as safe as, the vehicle in alleviating the postoperative pain associated with RK. This resulted in significant improvements in patient quality of life and less need for oral analgesics, suggesting that topical ketorolac is an appropriate treatment option for ocular pain following RK.

Adolescent↗

PubMedDate not supplied

Clinical evaluation of a new formula of timolol maleate (WP-934 ophthalmic solution). WP-934 Study Group.

We investigated the ocular hypotensive effect and possible adverse reactions of a new timolol maleate formula, WP-934 ophthalmic solution, which is timolol maleate solution dissolved in a reversible thermo-setting gel. Once-daily instillation of 0.25 or 0.5% WP-934 ophthalmic solution was administered in a prospective, randomized manner at 29 institutions for 8 weeks to patients with primary open-angle glaucoma or ocular hypertension, and for another 16 weeks in a limited number of these patients. Patients were closely monitored throughout the study by ophthalmic and systemic examinations, and by continuous evaluation of symptoms. The new timolol formula demonstrated a significant ocular hypotensive effect throughout the study period. Adverse effects were minor. WP-934 ophthalmic solution, timolol maleate dissolved in a reversible thermo-setting gel, has a significant ocular hypotensive effect in eyes with primary open-angle glaucoma and ocular hypertension.

Administration, Topical↗

PubMed2002

Naproxen ophthalmic solution to manage inflammation after phacoemulsification.

PURPOSE: To explore the efficacy and safety of 2 concentrations (0.1% and 0.2%) of sodium naproxen ophthalmic solution in controlling ocular inflammation in patients having phacoemulsification and intraocular lens implantation. SETTING: Service d'Ophtalmologie La Pitie' and Centre Ophtalmologique, Paris, and Clinique Sourdille, Nantes, France; Department of Ophthalmology, University of Lausanne, Switzerland. METHODS: One hundred one patients were randomly treated with naproxen 0.1%, naproxen 0.2%, or diclofenac 0.1% 3 times a day for 30 days starting the day before surgery. Postsurgical ocular inflammation was measured after 1, 10, and 30 days using the Kowa FC-1000 laser flare-cell meter and a conventional slitlamp biomicroscope. Safety parameters were evaluated at the same visits. RESULTS: Naproxen 0.2% ophthalmic solution and diclofenac 0.01% were comparable in controlling postsurgical inflammation. The naproxen was well tolerated. No serious adverse events occurred during the study. CONCLUSIONS: These preliminary results suggest that naproxen ophthalmic solution may be effectively and safely used to control inflammation after uneventful phacoemulsification. Because of the limited number of patients, larger studies are needed to confirm these results.

Anterior Chamber↗

PubMed2005

Microbiological assay for the determination of azithromycin in ophthalmic solutions.

The validation of a simple, sensitive and specific agar diffusion bioassay, applying cylinder-plate method, for the determination of the antibiotic azithromycin in ophthalmic solutions is described. Using a strain of Bacillus subtilis ATCC 9372 as the test organism, azithromycin at concentrations ranging from 50.0 to 200.0 microg.mL(-1) could be measured in 1.6667 mg.mL(-1) ophthalmic solutions. A prospective validation of the method showed that the method was linear (r = 0. 999 9) and precise (RSD = 0. 70) and accurate (it measured the added quantities). The results obtained by bioassay method could be statistically calculated by linear parallel model and by means of regression analysis and verified using analysis of variance (ANOVA). We conclude that the microbiological assay is satisfactory for quantification of azithromycin in ophthalmic solutions.

Anti-Bacterial Agents↗

PubMed1983

Respiratory arrest following first dose of timolol ophthalmic solution.

Within 30 minutes of the administration of his first dose of timolol ophthalmic solution, a 67-year-old man with stable chronic obstructive pulmonary disease experienced severe dyspnea leading to respiratory arrest. He recovered after endotracheal intubation and mechanical ventilation. Patients with bronchospastic pulmonary disease who are candidates for therapy with timolol ophthalmic solution should receive their first dose under medical supervision and should have continued close medical follow-up for as long as they receive timolol.

Aged↗

PubMed1986

Stability of pilocarpine hydrochloride and pilocarpine nitrate ophthalmic solutions submitted by U.S. hospitals.

The stability of pilocarpine hydrochloride and pilocarpine nitrate ophthalmic solutions stored in hospital pharmacies across the United States was studied. Through a voluntary drug stability program, FDA selected 252 samples (representing 11 manufacturers) from pharmacies representing an adequate cross section of the country. The samples were analyzed for strength, identification, pH, and isopilocarpine and pilocarpic acid impurities. All samples of pilocarpine nitrate met USP requirements. Eight samples of pilocarpine hydrochloride had tablets that exceeded the USP upper limit for strength. All of these samples were in 1- and 2-mL bottles. The amount of isopilocarpine found ranged from 1 to 6.4%, and the amount of pilocarpic acid from 1.5 to 10.1%. Although pilocarpine salts in ophthalmic solution decompose into isopilocarpine and pilocarpic acid under various conditions of storage, an amount of pilocarpine is maintained that is within the compendial limits. However, there is a problem of evaporation from some of the 1- and 2-mL containers in which this product is supplied.

Drug Contamination↗

PubMedDate not supplied

The effect of the corneal epithelium on the intraocular penetration of fluoroquinolone ophthalmic solution.

PURPOSE: Pharmacokinetic studies of antibacterial agents for infectious eye diseases have usually been performed on normal rabbit eyes. In this study, the intraocular penetration of fluoroquinolone ophthalmic solutions was determined in normal rabbit eyes and in rabbit eyes that had the corneal epithelium intentionally removed. METHODS: We determined the intraocular penetration of ofloxacin (OFLX), levofloxacin (LVFX), and norfloxacin (NFLX), fluoroquinolone ophthalmic solutions that are already on the market and undergoing clinical studies, by injecting 50 microl of each solution into the cul-de-sacs of rabbit eyes three times at 15-min intervals. The drug concentration at 10, 30, 60, 120, and 240 min after final instillation was determined by high-performance liquid chromatography. RESULTS: The maximum concentration in the aqueous humor of normal rabbit eyes was 2.09 +/- 1.56 microg/ml (60 min, OFLX), 2.57 +/- 1.00 microg/ml (30 min, LVFX), and 0.42 +/- 0.12 microg/ml (120 min, NFLX). The drug concentration in the aqueous humor of eyes with intentionally removed corneal epithelium was 12.50 +/- 5.62 microg/ml (30 min, OFLX), 9.02 +/- 2.45 microg/ml (60 min, LVFX), and 8.54 +/- 5.17 microg/ml (30 min, NFLX). The drug penetration of the eye drops into eyes with removed corneal epithelium was around 6 times (OFLX), 3.5 times (LVFX), and 20 times (NFLX) higher than the penetration into the eye with normal cornea. CONCLUSION: Among the pharmacokinetic parameters of the three ophthalmic solutions according to the one-compartment model, the maximum concentration in the aqueous and the area under the concentration-time curve in the aqueous tended to be higher in the eyes with intentionally removed corneal epithelia than in those with normal corneas.

Animals↗

PubMed1997

Effects of mucin ophthalmic solution on epithelial wound healing in rabbit cornea.

To test the hypothesis that a mucin ophthalmic solution could accelerate the healing of corneal epithelium, we conducted a study in rabbits using an ophthalmic solution containing mucin extracted from bovine submaxillary gland. The corneas of rabbits were abraded with a razor blade in the central portion over an area demarcated with a 7-mm trephine. Mucin-containing eye drops were instilled into the right eye 4 times a day for 3 days, and the vehicle was instilled into the left eye. After enucleation, the eyes were observed by scanning and transmission electron microscopy as well as light microscopy. Mucin-containing eye drops were shown to reduce the epithelial defect area more rapidly than the vehicle. Thus, the eye drops accelerated corneal epithelial wound healing.

Animals↗

PubMedDate not supplied

Efficacy of two chondroitin sulfate ophthalmic solutions in the therapy of spontaneous chronic corneal epithelial defects and ulcerative keratitis associated with bullous keratopathy in dogs.

OBJECTIVE: To determine the efficacy of two antimicrobial-chondroitin sulfate ophthalmic solutions in the therapy of spontaneous chronic corneal epithelial defects (SCCED) and ulcerative keratitis associated with bullous keratopathy in dogs. ANIMALS STUDIED: Eighty dogs with SCCED and 14 dogs with ulcerative keratitis associated with bullous keratopathy. PROCEDURE: Following manual debridement of nonadherent epithelium, dogs were treated topically with a chondroitin sulfate ophthalmic solution containing either tobramycin or ciprofloxacin. Patients were re-evaluated at 2-week intervals for 4 weeks. RESULTS: After 2 weeks of treatment, 53.6% of eyes with SCCED and 17.6% of eyes with ulcerative keratitis associated with bullous keratopathy had healed. After 4 weeks of treatment, 81.0% of eyes with SCCED and 23.5% of eyes with ulcerative keratitis associated with bullous keratopathy had healed. There were no statistically significant differences in healing percentages between the tobramycin-chondroitin sulfate solution treatment groups and the ciprofloxacin-chondroitin sulfate solution treatment groups. Two dogs with SCCED, one treated with the tobramycin-chondroitin sulfate solution and the other treated with the ciprofloxacin-chondroitin sulfate solution, developed sterile corneal stromal abscesses during the study. CONCLUSIONS: Topical therapy with an antimicrobial-chondroitin sulfate ophthalmic solution combined with manual debridement of nonadherent epithelium compares favorably with other published medical and surgical therapies for SCCED; however, these compounds are only equivocally more effective than therapy with manual debridement alone. These solutions appear to be ineffective in the treatment of ulcerative keratitis associated with bullous keratopathy. The significance of the two cases of corneal stromal abscessation is unknown at this time and warrants further investigation.

Administration, Topical↗

PubMed2005

Effectiveness of combined antibiotic ophthalmic solution in the treatment of hordeolum after incision and curettage: a randomized, placebo-controlled trial: a pilot study.

The presented pilot study compared the effectiveness of combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin) with a placebo (artificial tear) in the treatment of hordeolum after incision and curettage (I&C). A randomized, placebo-controlled trial with patients and investigators blinded from the start started from June 2002 to May 2003. Subjects were patients with untreated hordeolum who subsequently underwent I&C at the Ophthalmology Department. The patients were randomized into 2 groups: group A for combined antibiotic ophthalmic solution, and group B for artificial tear containing the antibiotic solution base. Pain score, mass size and duration of cure were recorded before and on the 3rd and 7th day after treatment. The study included 14 patients in each group. Two subjects in group A and three subjects in group B dropped out. There were no statistically significant differences of all outcomes in both groups, even with the intention-to-treat analysis. The conclusion is combined antibiotic ophthalmic solution is not more effective than placebo in the treatment of hordeolum after I&C.

Anti-Bacterial Agents↗

PubMed1989

Cytotoxicity and mutagenicity of ophthalmic solution preservatives and UVA radiation in L5178Y cells.

Four chemical preservatives commonly used in ophthalmic solutions were tested for their toxic and mutagenic potential in mouse lymphoma cells with and without exposure of the cells to ultraviolet A (UVA) radiation. The preservatives tested were benzalkonium chloride (BAK), chlorhexidine, thimerosal and ethylenediaminetetraacetic acid (EDTA). Cell survival and mutagenesis were measured using the L5178Y mouse lymphoma (TK +/-) system. Cells were exposed to varying amounts of preservatives for 1 h at 37 degrees C, and then aliquots were irradiated with UVA radiation (during the exposure to preservative). Cells were then assayed for survival, and for mutagenesis at the thymidine kinase (TK) locus. In concentrations commonly found in ophthalmic solutions, BAK, chlorhexidine, and thimerosal were toxic to cells, and thimerosal was slightly mutagenic. When cells were exposed to preservative and UVA radiation, chlorhexidine was mutagenic and the mutagenic activity of thimerosal was enhanced.

Animals↗

PubMed1998

Effects of viscoelastic ophthalmic solutions on cell cultures.

The development of mild but significant inflammation probably attributable to viscoelastic ophthalmic solutions in cataract surgery was recently brought to the notice of the authors, and hence a study of the effects of these solutions available in India, on cell cultures was undertaken. We studied the effects of 6 viscoelastic ophthalmic solutions (2 sodium hyaluronate designated as A and B, and 4 hydroxypropylmethylcellulose designated as C, D, E and F) on HeLa, Vero and BHK-21 cell lines in tissue culture microtitre plates using undiluted, 1:10 and 1:100 dilutions of the solutions, and in cover slip cultures using undiluted solutions. Phase contrast microscopic examination of the solutions was also done to determine the presence of floating particles. The products D and F produced cytotoxic changes in HeLa cell line and these products also showed the presence of floating particles under phase contrast microscopy. Other products did not have any adverse effects on the cell lines nor did they show floating particles. The viscoelastic ophthalmic pharmaceutical products designated D and F have cytotoxic effects on HeLa cell line which appears to be a useful cell line for testing these products for their toxicity. The presence of particulate materials in products D and F indicates that the methods used for purification of the solution are not effective.

Animals↗

PubMed1999

The survival of herpes simplex virus in multidose office ophthalmic solutions.

PURPOSE: To determine the survival of herpes simplex virus type 1 (HSV-1) in several multidose ophthalmic solutions. METHODS: In three separate trials, 10 aliquots of 5 ml each of three common multidose topical ophthalmic solutions, sodium fluorescein, proparacaine, and nonpreserved artificial tears, were inoculated with 10(5), 10(4), and 10(3) pfu per ml of HSV-1. All samples were titered on A549 cells at various time points for surviving HSV-1. RESULTS: Herpes simplex virus type 1 was not recovered from the fluorescein and proparacaine solutions at 1 hour or any time thereafter, regardless of inoculation titer. Herpes simplex virus type 1 was recovered from the artificial tears up to 7 days. CONCLUSION: Unlike adenovirus, HSV-1 does not survive in preserved fluorescein and proparacaine multidose solutions; therefore, office transmission is highly unlikely.

Benzalkonium Compounds↗

PubMed2007

Safety of prophylactic intracameral moxifloxacin 0.5% ophthalmic solution in cataract surgery patients.

PURPOSE: To determine the safety of prophylactic intracameral moxifloxacin 0.5% ophthalmic solution (Vigamox) in patients having cataract surgery. SETTING: American Eye Center, Manila, Philippines. METHODS: Preoperative and 1-month postoperative anterior chamber reaction, corneal endothelial cell density, and corneal thickness were assessed in 65 eyes that had cataract surgery with intracameral moxifloxacin. All eyes received 0.1 mL intracameral moxifloxacin 0.5% ophthalmic solution containing 500 mug of moxifloxacin as the last step of phacoemulsification. Different ophthalmologists conducted the postoperative evaluation in an observer-masked fashion. A P value less than 0.05 was considered significant. RESULTS: All 65 eyes completed the study. The mean age was 69.5 years +/- 9.13 (SD) (range 48 to 84 years). All eyes had a postoperative best corrected visual acuity of 20/30 or better. All eyes had trace to +2 cells and flare anterior chamber reaction only on the first day after surgery. The mean endothelial cell count was 2491.52 cells/mm(2) preoperatively and 2421.58 cells/mm(2) postoperatively. The mean difference was 70 cells/mm(2), which not statistically significant (P = .737). The increase of 17.80 microm in postoperative pachymetry 1 month after surgery was not statistically significant (P>.65). CONCLUSION: Intracameral Vigamox 0.5 mg/mL appeared to be nontoxic in terms of visual rehabilitation, anterior chamber reaction, pachymetry, and corneal endothelial cell density.

Aged↗

PubMedDate not supplied

Fixed-dose combination of 0.1% diclofenac plus 0.3% tobramycin ophthalmic solution for inflammation after cataract surgery: a randomized, comparative, active treatment-controlled trial.

PURPOSE: To assess the efficacy, tolerance, and ocular tolerability of a fixed-dose combination of 0.1% diclofenac plus 0.3% tobramycin ophthalmic solution compared with 0.1% diclofenac (Voltaren) and 0.3% tobramycin (Tobrex) in patients undergoing cataract extraction by either nuclear expression (extracapsular) or ultrasound-assisted aspiration (phacoemulsification) with intraocular lens implantation. METHODS: Eighty-eight patients undergoing cataract extraction with intraocular lens implantation participated in a randomized, parallel, observer-masked trial, in which the clinical usefulness of a fixed-dose combination of 0.1% diclofenac plus 0.3% tobramycin ophthalmic solution, two eyedrops every 6 hours (n = 44) was compared with Voltaren and Tobrex, one drop of each every 6 hours (n = 44) in a 22-day course. Efficacy was assessed from changes of the sum of anterior chamber cell count plus flare, conjunctival hyperemia and edema, and ciliary congestion, by means of slit lamp biomicroscopy on days 1, 7, 14, and 21. Tolerance and ocular tolerability were assessed by recording intraocular pressure (IOP), side effects, and the patient's and investigator's opinions. RESULTS: Anterior chamber cell count plus flare showed no differences in the two treatment groups at any evaluation point. The study treatment was associated with a significantly higher score for conjunctival edema on day 1 (p = 0.015), conjuncitval hyperemia on day 14 (p = 0.009) and anterior chamber cell count on day 21 (p = 0.04), but these differences had no clinical relevance. No side effects related to the study treatment were recorded. CONCLUSIONS: Efficacy, tolerance, and ocular tolerability of a fixed-dose combination of 0.1% diclofenac plus 0.3% tobramycin ophthalmic solution were comparable to Voltaren plus Tobrex for the control of anterior chamber inflammation after cataract surgery, with the advantage that both active principles are supplied in a single container.

Aged↗

PubMed2004

Daily cost of ophthalmic solutions used to treat allergic conjunctivitis in Japan.

PURPOSE: To estimate the daily cost of various ophthalmic solutions used in Japan for treating allergic conjunctivitis, including nine anti-allergic drugs and six anti-inflammatory drugs. METHODS: The drops contained in one bottle of each solution were counted. The cost per drop was calculated by dividing the government-controlled standard prices by the total number of drops in one bottle, and the daily cost of therapy was calculated by multiplying the cost per drop by the number of drops to be given per day. RESULTS: The total number of drops of the anti-allergic drugs in a bottle ranged from 108 to 169 and that of the anti-inflammatory drugs from 100 to 145. The information in the package insert for these solutions recommends application 2-4 times daily. The price of the antiallergic drugs studied ranged from $6.35 to $8.38 and that of the anti-inflammatory drugs studied from $2.02 to $5.20. The daily cost of the anti-allergic drugs studied varied considerably, from $0.26 to $0.57; for the anti-inflammatory drugs the range was from $0.12 to $0.20. Variations in the total number of drops per bottle and in the recommended dosage affect the daily cost of ophthalmic solutions. CONCLUSIONS: At current prices, the volume of a drop and the dosage had a greater effect on the daily cost than the price of a bottle. Daily cost data may be helpful in selecting ophthalmic products for treating allergic conjunctivitis in settings where the prices of a given drug are relatively uniform.

Anti-Allergic Agents↗

PubMed2000

Safety and efficacy of diclofenac ophthalmic solution in the treatment of corneal abrasions.

STUDY OBJECTIVE: To determine whether the use of diclofenac ophthalmic solution is a safe and effective analgesic in the treatment of traumatic corneal abrasions in the emergency department. METHODS: We conducted a prospective, randomized, double-blinded, placebo-controlled clinical trial. Consenting consecutive patients with corneal abrasions who presented to a community-based ED from August through February 1998 were randomly assigned to receive either diclofenac or control vehicle drops. Pain relief was measured using a visual Numeric Pain Intensity Scale (NPIS) before and after treatment. Exclusion criteria were as follows: age younger than 18 years, pregnancy, history of glaucoma, ocular infection, recent eye surgery, other signs of ocular trauma, narcotics within 6 hours, minimal pain (NPIS score <3), and any allergy to diclofenac or nonsteroidal anti-inflammatory drugs. Patients were discharged with study drug or control vehicle solution, a topical antibiotic, oxycodone-acetaminophen as a rescue analgesic, and a pain diary. The outcome measurements were improvement in NPIS score 2 hours after treatment, use of oxycodone-acetaminophen, and occurrence of any adverse effects. RESULTS: Forty-nine patients were enrolled in the study; 25 received diclofenac and 24 received control vehicle drops. Both groups were similar in gender, age, pretreatment pain duration, NPIS score, and analgesic use. There was significantly greater improvement in the 2-hour NPIS score in the diclofenac group (3.1; 95% confidence interval [CI] 2.3 to 4) compared with the control group (1.0; 95% CI 0.1 to 2.0). The difference between the 2 groups was 2.1+/-1.3 (95% CI 0.8 to 3.4). There was a trend toward fewer patients taking rescue oxycodone-acetaminophen in the diclofenac group (20%; 95% CI 4% to 36%) versus the control group (42%; 95% CI 22% to 62%). Other than transient mild stinging, there were no complications associated with diclofenac use. CONCLUSION: Diclofenac ophthalmic solution appears to be a safe and effective analgesic in the treatment of traumatic corneal abrasions in the ED.

Acetaminophen↗

PubMed2001

Iridial pigmentation induced by latanoprost ophthalmic solution in Japanese glaucoma patients.

PURPOSE: To investigate the incidence of iridial pigmentation induced by latanoprost ophthalmic solution in Japanese glaucoma patients by a prospective and observer-masked study. PATIENTS AND METHODS: Sixty-nine eyes of 69 glaucoma patients were included. Patients who had undergone intraocular surgery, laser trabeculoplasty, and laser iridotomy within 12 months before enrollment, and patients with history of uveitis and any changes in antiglaucoma drugs within 6 months before enrollment were excluded. Iridial photographs were taken by one examiner under the same conditions at 1, 3, and 6 months after the initiation of latanoprost treatment. Three glaucoma specialists, masked of patient information, independently assessed the iridial pigmentation. Cases with iridial pigmentation diagnosed by three specialists were categorized as showing a definite increase in iridial pigmentation. RESULTS: A definite increase in iridial pigmentation occurred in 3.5%, 9.7%, and 35.0% of eyes within 1, 3, and 6 months of treatment, respectively. Age, gender, or concomitantly used eyedrops did not significantly influence the incidence of iridial pigmentation within 6 months of instillation. A reduction of intraocular pressure by latanoprost did not differ significantly between patients with and without iridial pigmentation. CONCLUSION: The incidence of iridial pigmentation by latanoprost ophthalmic solution in Japanese patients was higher than previously reported values in pigmented races.

Adult↗