Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis.

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Treatments: Ketotifen; Naphazoline; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.

• Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.

• Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of instillation of the last titration of allergen at visit 1.

• Positive bilateral CAC reaction in at least 2 out of 3 time points at visit 2.

Exclusion Criteria:

• Known contraindications or sensitivities to the study medication or its components.

• Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.

• Use of disallowed medications during the period indicated prior to study enrollment or during the study.