Randomized, phase III study comparing osmoprotective carboxymethylcellulose with sodium hyaluronate in dry eye disease.

PURPOSE: To compare a treatment containing carboxymethylcellulose (CMC) and the osmoprotective (OsPr) compatible osmolytes erythritol, L-carnitine, and glycerin (OsPr-CMC) with a standard sodium hyaluronate (Na-HY) formulation in patients with dry eye disease. METHODS: This was a 3-month, phase III, noninferiority study. Patients were randomized 1:1 to receive OsPr-CMC (OPTIVE®) or Na-HY (VISMED®). The primary efficacy outcome was the mean change from baseline in total ocular staining at day 35, scored using the 15-point Oxford scale. Noninferiority was assessed using the adjusted means. The secondary efficacy outcome was change in ocular surface disease index (OSDI) score from baseline to day 35. Other outcomes included tear osmolarity, Schirmer-I test score, OSDI, ease of use, patient acceptability, tolerability, and safety. RESULTS: A total of 82 patients were randomized. The primary efficacy analysis was per protocol (OsPr-CMC, n=37; Na-HY, n=29). OsPr-CMC was noninferior to Na-HY in terms of adjusted mean change (SE) in ocular staining score at day 35: -2.0 (0.33) with OsPr-CMC vs -1.7 (0.37) with Na-HY. Similar improvements were seen in tear osmolarity, Schirmer-I test score, OSDI, and ocular staining for OsPr-CMC and Na-HY. More patients treated with OsPr-CMC vs Na-HY liked using their eyedrops, reported that their eyes felt comfortable, and found the treatment easy to use. Both treatments were well tolerated, with no serious treatment-related adverse events. CONCLUSIONS: Compared with Na-HY, OsPr-CMC was noninferior in terms of efficacy and safety, preferred by patients, and easier to use. Osmoprotection using OsPr-CMC therefore represents a viable option for dry eye disease management.

Efficacy and safety of azithromycin 1.5% eye drops for purulent bacterial conjunctivitis in pediatric patients.

BACKGROUND: Purulent bacterial conjunctivitis affects all ages with high frequency in newborns and children. In a subset of 150 children included in a large study having enrolled 1043 patients, our aim was to analyze in children, the efficacy and safety of azithromycin 1.5% eye-drops in the treatment of this disease. METHODS: This multicenter, randomized, investigator-masked, parallel-group study, included 150 children and adolescents to study safety and compare azithromycin 1.5% eye drops twice daily for 3 days and tobramycin 0.3% 1 drop every 2 hours for 2 days then 4 times daily for 5 days. Out of 150 patients included, 58 had positive cultures and were studied for efficacy. Signs and symptoms were evaluated and cultures obtained at baseline, Days 3 and 9. Primary efficacy variable was the clinical cure (score 0 for bulbar conjunctival injection and purulent discharge) at the test of cure visit (day 9). RESULTS: Both treatments were effective with a clinical and microbiologic cure of more than 80% of children on day 9. Azithromycin therapy provided a greater bacteriologic cure on day 3 than did tobramycin (P < 0.001) and eradicated bacteria that were defined as resistant, using classical antibiogram. No adverse effects were noted on the ocular surface. CONCLUSIONS: Azithromycin 1.5% eye drops leads to a rapid clinical and microbiological cure.

Efficacy and safety of short duration azithromycin eye drops versus azithromycin single oral dose for the treatment of trachoma in children: a randomised, controlled, double-masked clinical trial.

AIMS: Efficacy and safety of a short-duration treatment of azithromycin 1.5% eye drops versus oral azithromycin to treat active trachoma. METHODS: Randomised, controlled, double-masked, double-dummy, non-inferiority explanatory study including 670 children from Guinea Conakry and Pakistan if: 1-10 years old; active trachoma (TF+TI0 or TF+TI+ on simplified World Health Organisation (WHO) scale). Three groups received either: azithromycin 1.5% eye drops twice daily for 2 days, for 3 days or azithromycin single 20 mg/kg oral dose. Patients' contacts were treated whenever possible. Clinical evaluation was performed using a binocular loupe. Primary efficacy variable was the cure (no active trachoma (TF0)) at day 60. Non-inferiority margin for difference between cure rates was 10%. RESULTS: Cure rate in per protocol set was as follows: 93.0%, 96.3% and 96.6% in 2-day group 3-day group, and oral treatment group, respectively. Azithromycin 1.5% groups were non-inferior to oral azithromycin. The intend to treat (ITT) analysis supported the results. Clinical re-emergence rate was low: 4.2%. Ocular tolerance was similar for all groups. No treatment related adverse events were reported. Logistic regression analyses found prognostic factors such as: country (p<0.001) and trachoma severity (p = 0.003). CONCLUSIONS: In active trachoma, azithromycin eye drops twice daily for 2 or 3 days are as efficient as the WHO's reference treatment and represent an innovative alternative to oral azithromycin.

3-day treatment with azithromycin 1.5% eye drops versus 7-day treatment with tobramycin 0.3% for purulent bacterial conjunctivitis: multicentre, randomised and controlled trial in adults and children.

AIM: To compare the efficacy and safety of Azyter, azithromycin 1.5% eye drops, for 3 days with tobramycin 0.3% for 7 days to treat purulent bacterial conjunctivitis. METHODS: This was a multicentre, randomised, investigator-masked study including 1043 children and adults with purulent bacterial conjunctivitis. Patients received either azithromycin 1.5% twice-daily for 3 days or tobramycin 0.3%, 1 drop every two hours for 2 days, then four times daily for 5 days. Clinical signs were evaluated and cultures obtained at D0, D3 and D9 (where D refers to "day"). Primary variable was the clinical cure at the Test-of-Cure (TOC)-visit (D9+/-1), for patients with D0-positive cultures. The cure was defined as: bulbar conjunctival injection and discharge scores of 0. RESULTS: Among 471 patients with D0-positivity in the per protocol set, 87.8% of the azithromycin 1.5% group and 89.4% of the tobramycin group were clinically cured at the TOC-visit. Azithromycin was non-inferior to tobramycin for clinical and bacteriological cure. Clinical cure was significantly higher with azithromycin 1.5% at D3. The safety profile of azithromycin was satisfactory with a good patient and investigator's acceptability. CONCLUSIONS: Azithromycin 1.5% for 3 days was as effective and as safe as tobramycin for 7 days. Furthermore, more azithromycin than tobramycin patients presented an early clinical cure at Day 3. Due to its twice daily dosing regimen for 3 days, azithromycin represents a step forward in the management of purulent bacterial conjunctivitis, especially in children.

Effect of povidone 2% preservative-free eyedrops on contact lens wearers with computer visual syndrome: pilot study.

PURPOSE: To show that the use of povidone 2% preservative-free lubricating eyedrops reduces computer visual syndrome in contact lens wearers and to identify the best eyedrop instillation protocols. METHODS: The test product was FILMABAK a CE-marked nonpreserved lubricant, povidone 2% delivered by the ABAK system. Three dispensing modalities were evaluated during contact lens wear and computer use: hourly instillation, symptom-related instillation, and patient's own instillation. RESULTS: During sustained computer use, a decrease in symptoms associated with the use of povidone 2% was statistically and clinically significant. However, the symptoms were not fully eliminated by the use of the test eyedrop. The three instillation routines achieved similar beneficial effects. No significant changes in ocular tissue response were observed, and the staining recorded after sustained computer use remained low. The use of povidone 2% preservative-free lubricating eyedrops under any of the three instillation modalities tested was also associated with a slight improvement in dynamic visual acuity. CONCLUSIONS: The use of povidone 2% preservative-free eyedrops was associated with an improvement in symptoms during sustained computer use. Any of the three instillation modalities decreased symptoms of ocular tiredness, dryness, and difficulty of focus; maintained an unchanged corneal surface; and improved dynamic visual acuity. Therefore, the most patient-friendly modality (patient's own instillation modality from symptom onset) could be recommended to contact lens wearers with computer visual syndrome.

Preservative-free ocular hydrating agents in symptomatic contact lens wearers: saline versus PVP solution.

PURPOSE: To compare two preservative-free hydrating agents, in multidose (ABAK) bottles, in contact lens wearers experiencing symptoms of ocular dryness. METHODS: The endpoint of this 4-week multicenter, randomized, double-blind, parallel-group study comparing a 2% polyvinylpyrrolidone (PVP) solution with a 0.9% NaCl solution was to assess ocular discomfort using a visual analog scale. A biomicroscopic examination and a test of tolerability on instillation were also performed, and adverse events were recorded. RESULTS: Thirty-nine subjects were enrolled (23 PVP; 16 NaCl). The average age was 30; subjects were predominantly female, and mostly wore frequent-replacement contact lenses. They were all exposed to environmental factors such as routine use of video monitors or air conditioning. The two groups were similar at baseline (D0). Both PVP and NaCl improved the comfort of contact lens wear (P = 0.0003), with no difference between them (P = 0.25). The mean daily duration of lens wear and the daily number of instillations to relieve discomfort (4.2 +/- 2.0 for PVP ABAK; 4.6 +/- 1.9 for NaCl ABAK) were comparable. However, PVP use led to more favorable evolution of fluorescein-staining corneal punctuations (P = 0.028). Safety was good, with minimal adverse events considered unrelated to the products. Lens wettability was excellent, and there were no clinically relevant deposits. Most subjects also found the ABAK bottles convenient. CONCLUSIONS: Ocular hydration improves comfort in contact lens wearers. NaCl is an appropriate first-line treatment, but for subjects with fluorescein-staining punctuations, lubrication with PVP is preferable.