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.

Efficacy and safety of azithromycin 1.5% eye drops in paediatric population with purulent bacterial conjunctivitis.

OBJECTIVE: To determine the efficacy and safety of azithromycin 1.5% eye drops in a paediatric population with purulent bacterial conjunctivitis. PATIENTS AND METHODS: This was a multicentre, international, randomised, investigator-masked study in 286 children with purulent discharge and bulbar conjunctival injection. Patients received either azithromycin 1.5% eye drops (twice daily for 3 days) or tobramycin 0.3% eye drops (every 2 h for 2 days, then four times daily for 5 days). Clinical signs were evaluated on day (D) 0, 3 and 7, and cultures on D0 and D7. The primary variable was the clinical cure (absence of bulbar conjunctival injection and discharge) on D3 in the worse eye for patients with positive cultures on D0. RESULTS: 286 patients (mean age 3.2 years; range 1 day-17 years) were included; 203 had positive cultures on D0. Azithromycin was superior to tobramycin in clinical cure rate on D3 (47.1% vs 28.7%, p=0.013) and was non-inferior to tobramycin on D7 (89.2% vs 78.2%, respectively). Azithromycin treatment eradicated causative pathogens, including resistant species, with a similar resolution rate to tobramycin (89.8% vs 87.2%, respectively). These results were confirmed in a subgroup of patients younger than 24 months old. CONCLUSIONS: Azithromycin 1.5% eye drops provided a more rapid clinical cure than tobramycin 0.3% eye drops in the treatment of purulent bacterial conjunctivitis in children, with a more convenient twice-a-day dosing regimen.

Efficacy and safety of preservative-free latanoprost eyedrops, compared with BAK-preserved latanoprost in patients with ocular hypertension or glaucoma.

AIM: To compare efficacy (intraocular pressure (IOP) reduction) and safety of preservative-free latanoprost (T2345) to benzalkonium chloride (BAK)-preserved latanoprost (BPL; Xalatan) in ocular hypertension (OHT) or primary open angle glaucoma (POAG) patients. METHODS: Prospective, international, multicentre, randomised, investigator-masked, parallel-group trial. After a wash-out period, POAG or OHT patients, previously managed by BPL monotherapy, randomly received T2345 or BPL (one drop into the affected eye(s)) once daily from D0 to D84. Change in IOP was measured at 09:00 (±1 h) from D0 to D84 in the worse eye. RESULTS: Mean IOP reduction (D0-D84) was -8.6±2.6 mm Hg (-36%) on T2345 and -9.0±2.4 mm Hg (-38%) on BPL, confirming non-inferiority of T2345 to BPL. Non-inferiority of T2345 was observed from D15. The most frequent ocular adverse event, drug intolerance, was reported in 1 (0.5%) patient on T2345 versus 4 (2.1%) patients on BPL. Moderate to severe conjunctival hyperaemia was less frequent on T2345 than on BPL at D42 (20.2% vs 30.6%; p=0.003) and D84 (21.4% vs 29.1%; p=0.02). Upon instillation, the global subjective ocular symptom score was significantly lower on T2345 than BPL on D42 (0.15 vs 0.41; p=0.001) and D84 (0.18 vs 0.46; p=0.001). CONCLUSIONS: Preservative-free latanoprost has the same efficacy as BPL, with improved local tolerance.

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.

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.