Biomedical subjects
Publications and source records attributed to C Trinquand.
The study of ocular drug penetration may take into account many factors connected to the ophthalmic route specificity: anatomical barriers of the eye, solubility, molecular weight and eyedrops concentration. The factors influencing ocular drug penetration are reviewed. The broad outlines of research focuses now on an increase of the bioavailability, a best tolerability and a reduction of systemic effects of drugs.
PURPOSE: To compare the effect of topical indomethacin 0.1% solution with the effect of topical dexamethasone 0.1% phosphate solution on signs and symptoms of inflamed pterygium and pinguecula. METHODS: Of 50 consecutive patients who had inflamed pterygia (n = 17) or pingueculae (n = 33), met the study criteria, and signed an informed consent, one eye of each patient was evaluated in a comparative, prospective, randomized, double-masked, controlled study. Objective signs (conjunctival congestion, redness and edema, and staining of cornea) and subjective complaints (photophobia, pain, foreign-body sensation, discomfort, and tearing) were evaluated and scored. We also evaluated "total signs," "total symptoms," and "total score." Group 1 (n = 25) received topical indomethacin 0.1% solution, and group 2 (n = 25) received a topical dexamethasone phosphate 0.1% solution six times daily for 3 days, then four times daily over the following 11 days. Patients were examined before treatment, on days 3, 7, and 14 after the treatment was initiated, and 2 and 4 weeks after the treatment was discontinued. RESULTS: In both groups, the scores for "total signs," "total symptoms," and "total score" were significantly lower (P = .001) by day 14. There were no differences between groups 1 and 2 for "total signs," "total symptoms," and "total score" at days 3, 7, and 14 (P = .07 to P = .88). After treatment was discontinued, the dexamethasone-treated group experienced a significantly greater recurrence of "total signs" (P = .023 at day 30, P = .02 at day 45), but there was no statistically significant difference in "total symptoms" and "total score." Patients in group 2 reported more stinging after drops were administered than patients in group 1 (P = .002). CONCLUSIONS: This study indicates that topical indomethacin 0.1% solution is as effective as topical dexamethasone phosphate 0.1% solution for the treatment of inflamed pterygium and pinguecula and, therefore, is suggested as an effective treatment for these conditions.
PURPOSE: To compare the efficacy and safety of two carbomer 940 eye gels in the treatment of dry eyes: Lacrinorm (also called GelTears), a recently introduced eye gel, and Viscotears (also called Vidisic or Lacrigel), used as a reference gel. The main difference between the two gels is in the preservative, respectively benzalkonium chloride and cetrimide. METHODS: A double-masked, randomised, parallel-group study was conducted in 16 centres in four European countries. A total of 179 patients suffering from aqueous-deficient dry eye were enrolled, of whom 92 were randomised to treatment with Lacrinorm and 87 to the reference gel. Gel was instilled four times a day for a period of 30 days. RESULTS: After 30 days of treatment, subjective symptoms (the combined scores of foreign body sensation, ocular dryness, burning or pain, and photophobia) had improved by 50% in the Lacrinorm group and by 45% in the reference gel group, and objective test results (break-up time, fluorescein test, Schirmer test, Lissamine Green test) by 35-36% in the Lacrinorm group and 25-45% in the reference group. The improvements were significant in both treatment groups (p < 0.001), with no significant differences between the treatment groups. Subjective local tolerability upon instillation on day 30 was rated 'good' or 'very good' by 91% of patients in both treatment groups. Adverse events were reported for 21 patients in the Lacrinorm group and 17 in the reference group, the most frequent being discomfort, blurred vision, hyperaemia, burning and itching. The frequency and descriptions of adverse events did not differ significantly between the two treatment groups. No serious adverse events were reported. CONCLUSIONS: Over the period of study, Lacrinorm eye gel was as effective and safe as Viscotears/Lacrigel in the treatment of dry eye.
PURPOSE: To compare the activity of topical 0.05% and 0.01% mequitazine versus vehicle in the prevention of allergic conjunctivitis induced by a conjunctival provocation test with allergens. METHODS: Forty subjects with a history of grass pollen allergic conjunctivitis were enrolled in this comparative, randomized, double-masked study. Fifteen minutes before the conjunctival provocation test, subjects received one instillation alone of 0.05% mequitazine eyedrops in one eye and in the fellow eye either one drop of 0.01% dose or vehicle, at the same dosage. Then a specific conjunctival provocation test (CPT) was performed with the allergen threshold concentration previously defined. The therapeutic efficacy was assessed by the decrease in a symptomatic composite score representing the allergic reaction. RESULTS: Topical mequitazine at the dose of 0.05% significantly decreases the intensity of the allergic reaction compared to vehicle. Moreover, the group treated with this dose needed a higher allergen concentration to trigger ocular signs. The 0.01% dose appears efficient only on itching, compared to vehicle. CONCLUSION: The results of this study support the efficacy and the onset of action of 0.05% mequitazine eyedrops versus 0.01% or vehicle in the prevention of allergic conjunctivitis induced by a conjunctival provocation test.
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Pharmacologic intervention in the management of allergic conjunctivitis was evaluated with different topical ocular agents in man. Their effect can be precisely assessed with the conjunctival provocation test (CPT). A potent specific H1-receptor antagonist, 0.05% mequitazine eye-drops, was tested in a double-blind randomized, placebo-controlled study using CPT with grass pollen allergens. Twenty healthy subjects allergic to grass pollen were included outside the pollen season after a positive CPT screening. They received one drop of 0.05% mequitazine in one eye and the vehicle in the contralateral eye in a random order, four times daily for 5 days. CPT was performed 15 min after the last instillation, and the threshold dose inducing a positive reaction was determined. Results were given by Abelson's composite score including redness, chemosis, tearing, and itching. Topical 0.05% mequitazine significantly reduced the composite score compared to placebo. The allergen threshold concentration which induced the positive conjunctival reaction was higher in mequitazine pretreated eyes. No side-effect was reported. These data clearly suggest that mequitazine has potential to treat allergic conjunctivitis.
PURPOSE: To evaluate the effect of topical indomethacin 0.1% on signs and symptoms in inflamed pterygium and pinguecula. METHODS: Fifty-one consecutive patients who had inflamed pterygium (n = 32) or pinguecula (n = 19) were studied in a randomized, double-masked, controlled way. Objective signs (conjunctival congestion, redness, edema, and staining of cornea) and subjective complaints (photophobia, pain, foreign-body sensation, discomfort, and tearing) were evaluated and scored. In addition, we evaluated total signs, total symptoms, and total score. Group 1 (n = 25) received topical indomethacin 0.1% solution and group 2 (n = 26) received a placebo six times daily for 3 days, then four times daily for 11 days. Patients were examined before and at days 3, 7, and 14 after the treatment began. RESULTS: In group 1 at day 3, the scores of total signs, total symptoms, and total score decreased (p = 0.001), and they further decreased after 14 days (p = 0.02 to p = 0.05). In group 2 at day 3 these parameters also significantly decreased (p = 0.01 to p = 0.02), but no further improvement occurred after 14 days. Comparing groups 1 and 2 revealed a decrease in scores in group 1 for total signs, total symptoms, and total score at days 3, 7, and 14 (p = 0.03 to p = 0.002) except for total signs after 14 days (p = NS). All the patients reported mild stinging for < 1 min after administration of the drops. CONCLUSIONS: This study indicates that topical indomethacin solution 0.1% is a useful treatment for inflamed pterygium and pinguecula.
PURPOSE: To evaluate the efficiency and safety of LCM 1110 eyedrops, a new 0.1% indomethacin formulation, compared with the registered 0.1% indomethacin solution and with 0.1% diclofenac, in the management of post cataract surgery inflammation. METHODS: A total of 352 patients randomly assigned to LCM 1110 (n = 116), to indomethacin (n = 121) or to diclofenac (n = 115) were included in this three-arm, prospective, multicenter and double-masked trial, after giving written informed consent. They were given preoperatively 1 drop QID the day before surgery, 5 drops within 2 hours prior to operation then 1 drop QID for 1 month. Cataracts were extracted by either extracapsular or phacoemulsification methods, with PC-IOL implantation. The main efficacy evaluation was based on the assessments of anterior chamber cells and flare at days 1, 7 and 30 following surgery. Symptoms, other objective signs and IOP were recorded. RESULTS: Cellular and proteinic Tyndall phenomenon did not significantly differ in the 3 groups, at any of the post surgical assessments. Clinical symptoms and visual acuity improved similarly. IOP was not adversely affected by any drug. Compared with subjects having received LCM 1110, diclofenac-treated patients experienced a superficial punctuate keratitis more frequently. Tolerance of instillation, measured by a visual analogic scale, was best improved by LCM 1110 followed by the indomethacin solution and by diclofenac (LCM 1110-diclofenac; p = 0.004). CONCLUSION: These data suggest that LCM 1110, a new 0.1% indomethacin ophthalmic solution, appears to be a safe promising agent for the control of postoperative inflammation.
We evaluated the efficacy and safety of 0.1% indomethacin and 0.1% diclofenac solutions, in controlling pain post excimer laser photorefractive keratectomy (PRK). After written consent, 61 informed patients (23 males, 38 females; mean age = 33.5 +/- 8.4 yrs) were enrolled in a double-masked, randomized, comparative study and assigned to either indomethacin or diclofenac treatment. Subjective preoperative evaluation of individual susceptibility to pain evoked by topical application of 1% tetracaine vs saline served as reference for further post-operative pain measurement using a visual analog rating scale. Ocular and cephalic pain, itching, foreign body sensation, insomnia, photophobia, blepharospasm as well as systemic analgesic medication and alcohol intake were monitored for 3 days following photoablation as well as the re-epithelialization process. Both solutions significantly reduced pain on the first day following excimer laser PRK, and this activity was maintained until the end of the observation period. At Day 0 the first measure of pain level was slightly higher in the indomethacin group (p < 0.05) and could be related to a possible anaesthetic effect of Diclofenac. During the follow-up the oral intake of analgesics was higher in the diclofenac group, however this difference was not significant. Wound healing rate was not affected by indomethacin or diclofenac administration. These data suggest that both 0.1% indomethacin and 0.1% diclofenac ophthalmic solutions may help to control the pain induced by excimer laser PRK without any deleterious effect on corneal wound healing.
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PURPOSE: The aim of the study was to compare 2 combinations of anti-inflammatory drug and antibiotic, in patients undergoing cataract surgery: 0.1% indomethacin/gentamicin or 0.1% dexamethasone/ neomycin. METHODS: Two hundred and two patients undergoing extra-capsular cataract extraction with posterior chamber lens implantation were included in a randomized, double-blinded multicentric study comparing 2 parallel groups of treatment. Treatment was administered the day before surgery, the day of surgery and for the following 7 days. On the 8th post-operative day, the antibiotic was stopped and the anti-inflammatory treatment continued alone until the 30th post-operative day. Post-operative ocular inflammation was assessed clinically on the 1st, 7th, 15th and 30th post-operative days. The main evaluation criterion of treatment efficacy was the assessment of anterior chamber flare and cells. RESULTS: No statistically significant difference-was observed between the 2 treatment groups concerning post-operative inflammation. Both treatments were well tolerated. CONCLUSION: Eye drops combining 0.1% indomethacin and gentamicin proved to be effective and well tolerated in preventing inflammation after cataract surgery.
PURPOSE: The goal of this trial was to evaluate the efficacy (protective action on corneal endothelium and ability to facilitate the procedure) as well as safety (effect on intraocular pressure and inflammation) of Biovisc (new viscoelastic agent made of 1% sodium hyaluronate produced by bacterial fermentation) versus Healonid) postcataract surgery (manual or phacoemulsification). METHODS: 106 patients, 45 males and 61 females (31-94 years) were included in this prospective randomized multicentre trial and followed up for three months. Specular microscopy and intraocular pressure (IOP) measurement were the main evaluation criteria. RESULTS: At D 90, no significant difference was observed between the two viscoelastic agents on the mean endothelial cell loss (group Viovis: -8.6%; group Healonid: -6%) as well as on IOP (early peaks were transitory and resolutive). CONCLUSION: Biovisc and Healonid were similar in terms of efficacy and tolerance.
PURPOSE: The aim of the study was to compare 2 beta-blocker eye drops at a low concentration: 0.5% carteolol and 0.1% timolol. METHODS: The study was designed as a random-order, double-blinded comparison of 2 parallel treatment groups. Fifty patients with early primary open angle glaucoma or high intraocular pressure were included. The treatment lasted 4 weeks, on the basis of 1 drop twice daily. Diurnal I.O.P. curve was assessed with 4 measurements from 8.30 a.m. to 4.30 p.m. before and after treatment. The 8.30 a.m. measure of the final assessment of I.O.P. curve was established prior to morning medication. The mean values of the 4 measures were compared. RESULTS: Both treatments reduced IOP by a comparable amount: 4.25 +/- 1.2 mmHg (mean +/- SD) for carteolol and 4.69 +/- 1.9 mmHg for timolol. The decrease of IOP was found at every time of assessment, without any significant difference between treatments. Both eye drops were very well tolerated. CONCLUSION: The results of this study show that the new beta-blocker eye drop solution 0.5% carteolol is effective for initial management of high intraocular pressure.
A randomized, double-blind study was conducted to compare the effect of 0.1% indomethacin solution versus 0.03% flurbiprofen versus placebo on the maintenance of mydriasis during cataract surgery. Ninety-five patients undergoing extracapsular cataract extraction with posterior chamber lens implantation were enrolled. Pupillary diameters were measured horizontally under operating-microscope visualization before 5 surgical steps: 1. corneo-scleral incision; 2. lens nucleus expression; 3. lens cortex material aspiration; 4. intra-ocular lens implantation; 5. end of surgery. The mydriasis loss during surgery was statistically less in the 2 groups treated by non steroidal anti-inflammatory drugs than in the placebo group. This effectiveness appeared at the time of lens nucleus expression (p = 0.0001) and persisted until the end of surgery. Then, the mydriasis was maintained during 2 crucial surgical steps requiring optimal pupillary dilation: lens cortex material aspiration and intra-ocular lens implantation. No significant difference was found between 0.1% indomethacin and 0.03% flurbiprofen concerning effectiveness and tolerance.
To compare the effectiveness of subconjunctival injections and collagen shields in delivering anti-inflammatory agents and antibiotics after cataract surgery, we conducted a prospective study of 61 patients. They were randomly assigned to three groups: subconjunctival injection of gentamicin and dexamethasone; the same route plus a collagen shield without drug; collagen shield soaked in gentamicin and dexamethasone. All subjects had a manual extracapsular cataract extraction with posterior chamber intraocular lens implantation. Eyes were evaluated at the end of surgery and 24 hours later. The collagen shield achieved a progressive effect on pain and a decrease in conjunctival redness after 24 hours. The occurrence of folds in Descemet's membrane was less frequent and aqueous flare less severe than when subconjunctival injections were used. No adverse effect was reported. We conclude that the collagen shield could be a safe, better, noninvasive technique because of its double action of bandage and enhancement of drug penetration.
Acute salpingitis caused by Chlamydia trachomatis and other associated pathogens was diagnosed in 55 patients by means of laparoscopy and serological tests. All patients were treated with intravenous injections of doxycycline (200 mg/day) for four days followed by the same dosage orally for 20 days. Other antibiotics were given concomitantly for the associated infections. Treatment efficacy was evaluated on day 7 and day 30. Clinical symptoms had disappeared in 45 (82%) of the patients, and improvement was seen in another four (11%). Failure to improve in six cases was attributed to concurrent infection with microorganisms other than C trachomatis. After 30 days of treatment, two infections attributed to C trachomatis had not been cured with the doxycycline treatment; one of the patients was believed to have been reinfected and the other did not follow the prescribed treatment. The finding of clinical failure due to associated infection, sometimes discovered after two or three weeks of treatment, necessitates treatment of chlamydial salpingitis with multiple antibiotics, subsequent follow-up procedures (laparoscopic and serological), and appropriate changes in antibiotic therapy after C trachomatis has been eradicated but other pathogens remain.
PURPOSE: Twenty-two people with a history of grass pollen allergic conjunctivitis were enrolled outside the pollen season in this study to compare the efficacy of 0.05% mequitazine eyedrops with topical 2% disodium cromoglycate. METHODS: This randomized, double-blind study compared right and left eyes. Subjects received 2% disodium cromoglycate eyedrops in one eye and mequitazine vehicle in the fellow eye 4 times daily for 4 days. For the last instillation, mequitazine vehicle was replaced by one drop of 0.05% mequitazine and 15 min later a conjunctival provocation test (CPT) with grass pollen was performed. RESULTS: The sum of the scores for hyperemia and itching, and total composite score were lower after 0.05% mequitazine than after 2% disodium cromoglycate (p < 0.0001 in each case). The allergen threshold dose which elicited a positive allergic response was higher in the mequitazine group (p < 0.001). Both treatments showed good tolerance upon instillation. No adverse events related to study treatment occurred. CONCLUSIONS: These results demonstrate the superior efficacy of a single drop of 0.05% mequitazine 15 min before CPT compared with 2% disodium cromoglycate 4 times daily for 4 days.
The effects of carteolol 2% and a fixed combination of carteolol 2% and pilocarpine 2% (CBS 341 A) eye-drops on intraocular pressure (I.O.P.) were compared in a multicenter double-blind, cross-over prospective trial. Twenty-eight patients were initially selected after at least three weeks of carteolol 2%, with a morning I.O.P. greater than 21-mmHg. They received 2 drops a day (b.i.d.), in a random order, alternating two weeks of carteolol 2% alone or two weeks of CBS 341 A. After each two-week period a 12-h I.O.P. curve was plotted. Compared to carteolol the combination reduced I.O.P. on average by around 20% (4 mmHg), with maximum effect 4h after instillation. The effectiveness was confirmed after twelve hours. Some side effects were reported with CBS 341 A, due to the well known pharmacological effects of pilocarpine. The new combination could be useful for second-line therapy in glaucoma.