A randomized, double-masked, placebo-controlled parallel study of loteprednol etabonate 0.2% in patients with seasonal allergic conjunctivitis

• Published in: Ophthalmology (Rochester, Minn.) Vol. 106; no. 2; pp. 362 - 369
• Main Authors: Shulman, David G, Lothringer, Larry L, Rubin, Jay M, Briggs, Richard B, Howes, John, Novack, Gary D, Hart, Kathryn
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.02.1999; Elsevier
• Subjects: Adult; Aged; Androstadienes - administration & dosage; Androstadienes - adverse effects; Androstadienes - therapeutic use; Anti-Allergic Agents - administration & dosage; Anti-Allergic Agents - adverse effects; Anti-Allergic Agents - therapeutic use; Anti-Inflammatory Agents - administration & dosage; Anti-Inflammatory Agents - adverse effects; Anti-Inflammatory Agents - therapeutic use; Biological and medical sciences; Conjunctivitis, Allergic - drug therapy; Conjunctivitis, Allergic - physiopathology; Double-Blind Method; Female; Humans; Intraocular Pressure - drug effects; Loteprednol Etabonate; Male; Medical sciences; Middle Aged; Oculomotor disorders; Ophthalmic Solutions - administration & dosage; Ophthalmic Solutions - adverse effects; Ophthalmic Solutions - therapeutic use; Ophthalmology; Prospective Studies; Safety; Seasons; Treatment Outcome; Human; Loteprednol; Allergy; Immunopathology; Corticosteroid; Treatment efficiency; Multicenter study; Antiinflammatory agent; Vernal conjunctivitis; Conjunctiva disease; Eye disease; Chemotherapy; Ophthalmic preparation; Randomization; Treatment
• ISSN: 0161-6420; 1549-4713
• DOI: 10.1016/S0161-6420(99)90077-5

To evaluate the effects of loteprednol etabonate (LE) 0.2% in reducing the signs and symptoms of seasonal allergic conjunctivitis. Randomized, double-masked, placebo-controlled, parallel group multicenter study of 6 weeks duration. A total of 135 patients with signs and symptoms of seasonal allergic conjunctivitis participated. All patients received either LE 0.2% or placebo (vehicle) four times a day in both eyes for 42 days. Bulbar conjunctival injection (primary sign) and itching (primary symptom) over the first 2 weeks of treatment was measured. A reduction in severity was seen in both LE and placebo groups for bulbar conjunctival injection (1.5 vs. 1.0 units on a 0–3 scale) and itching (3.4 vs. 3.0 units on a 0–4 scale) over the first 2 weeks. The treatment effect by these measures was −0.5 and −0.4 units in favor of LE ( P ≤ 0.008). Resolution (i.e., the proportion of patients with signs or symptoms no longer present) at day 14 strongly favored LE-treated patients (36% and 15%; 58% and 38%, for injection and itching, respectively). Both treatments were well tolerated. One patient in each treatment group (1 of 67 and 1 of 68, respectively) had an elevation of intraocular pressure of 10 mmHg or greater during the 6 weeks of treatment. Loteprednol etabonate 0.2% was more effective than placebo in the treatment of seasonal allergic conjunctivitis. Loteprednol etabonate 0.2% had a safety profile comparable to placebo.