Overview

A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to ZaditorĀ® (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 ZaditorĀ® 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