A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model

• Status: Completed
• Trial end date: 2018-08-13
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of Bilastine ophthalmic solution 0.6% compared to vehicle and Zaditen (Ketotifen ophthalmic solution 0.025%) for the treatment of the signs and symptoms of allergic conjunctivitis.

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

Details

• Lead Sponsor: Faes Farma, S.A.
• Collaborator: ORA, Inc.
• Treatments: Ketotifen; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• be at least 18 years old

• be willing and able to avoid all disallowed medications and contact lenses

• must have a pregnancy test if of childbearing potential

• must be able to read an eye chart from 10 feet away

Exclusion Criteria:

• must not have any allergies to the study medications

• must not have any ocular or non ocular condition that investigator feels will interfere with study parameters

• must not have used immunotherapy in the last 2 years

• must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial