A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle

• Status: Completed
• Trial end date: 2018-04-29
• Target enrollment: 0
• Participant gender: All

Summary

A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the treatment of ocular itching.

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

Details

• Lead Sponsor: Bausch & Lomb Incorporated; EyeMax, LLC
• Collaborators: Eton Pharmaceuticals, Inc.; ORA, Inc.
• Treatments: Ketotifen; Ophthalmic Solutions

Criteria

Inclusion Criteria:

• be at least 18 years old

• have a positive history of allergic conjunctivitis and positive skin test reaction to allergens

• be willing to avoid disallowed medications for the appropriate washout period and throughout the trial

• be willing to avoid contact lens use

• be willing to have a pregnancy test

• 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 an investigational drug or device in the past 30 days or currently be enrolled in another investigational trial