Clinical Cure of Bacterial Conjunctivitis with Azithromycin 1%: Vehicle-Controlled, Double-Masked Clinical Trial

• Published in: American journal of ophthalmology Vol. 145; no. 6; pp. 959 - 965
• Main Authors: Abelson, Mark B, Heller, Warren, Shapiro, Aron M, Si, Erwin, Hsu, Peng, Bowman, Lyle M
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.06.2008; Elsevier; Elsevier Limited
• Subjects: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; Anti-Bacterial Agents - therapeutic use; Antibiotics; Azithromycin - administration & dosage; Azithromycin - adverse effects; Azithromycin - therapeutic use; Bacteria; Biological and medical sciences; Child; Child, Preschool; Clinical trials; Conjunctivitis, Bacterial - drug therapy; Conjunctivitis, Bacterial - microbiology; Double-Blind Method; Female; Gram-Negative Bacteria - drug effects; Gram-Negative Bacteria - isolation & purification; Gram-Negative Bacterial Infections - drug therapy; Gram-Negative Bacterial Infections - microbiology; Gram-Positive Bacteria - drug effects; Gram-Positive Bacteria - isolation & purification; Gram-Positive Bacterial Infections - drug therapy; Gram-Positive Bacterial Infections - microbiology; Humans; Infant; Laboratories; Male; Medical sciences; Microbial Sensitivity Tests; Middle Aged; Miscellaneous; Ophthalmic Solutions - administration & dosage; Ophthalmic Solutions - adverse effects; Ophthalmic Solutions - therapeutic use; Ophthalmology; Pharmaceutical Vehicles - administration & dosage; Pharmaceutical Vehicles - adverse effects; Pharmaceutical Vehicles - therapeutic use; Prospective Studies; Streptococcus infections; Studies; Azithromycin; Mask; Conjunctiva disease; Conjunctivitis; Macrolide; Infection; Eye disease; Antibiotic; Bacteriosis; Bacteria; Clinical trial; Protein synthesis inhibitor; Ophthalmology; Antibacterial agent
• ISSN: 0002-9394; 1879-1891
• DOI: 10.1016/j.ajo.2008.01.019

Purpose To analyze the effect of azithromycin 1% ophthalmic solution in DuraSite (InSite Vision, Inc, Alameda, California, USA) on bacterial conjunctivitis. Design Prospective, randomized, vehicle-controlled, parallel-group, double-masked multicenter clinical study. Methods Eligible male or female participants with a clinical diagnosis of acute bacterial conjunctivitis were randomized to either 1% azithromycin in DuraSite or vehicle for five days. Infected eyes were dosed twice daily on days 1 and 2 and once daily on days 3 through 5. Conjunctival cultures were obtained at baseline, visit 2 (day 3 or 4), and visit 3 (day 6 or 7). The primary end point was clinical resolution of signs and symptoms (rating of zero on ocular discharge, bulbar and palpebral injection) at visit 3. Efficacy measures were clinical resolution and bacterial eradication as evaluated in the per-protocol population. Safety was assessed by adverse events, slit-lamp findings, and ophthalmoscopy. Results Two hundred and seventy-nine participants (n = 130, 1% azithromycin in DuraSite; n = 149, vehicle), age one to 96 years, were evaluated for efficacy. Clinical resolution with azithromycin ophthalmic solution was statistically significant compared with that of vehicle ( P = .030) at visit 3. Bacterial eradication rates with azithromycin ophthalmic solution reached 88.5% at visit 3 ( P < .001) and included some pathogens resistant to azithromycin in vitro. Overall, adverse event rates were similar in both treatment groups. Conclusions Azithromycin 1% ophthalmic solution in DuraSite showed statistically significant differences in clinical resolution and bacterial eradication rates when compared with vehicle. Because it was well tolerated in this population, it may be a viable treatment option for children and adults with bacterial conjunctivitis.