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

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Allergic Conjunctivitis

Treatments: Drug: Vehicle; Drug: EM-100; Drug: Zaditor®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03489941

17-100-0011

Details and patient eligibility

About

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

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 3 patient groups

EM-100

Experimental group

Description:

One drop of EM-100 in either the right or left eye once on Day 1.

Treatment:

Drug: EM-100

Zaditor®

Experimental group

Description:

One drop of Zaditor® in either the right or left eye once on Day 1.

Treatment:

Drug: Zaditor®

Vehicle

Experimental group

Description:

One drop of Vehicle in either the right or left eye once on Day 1.

Treatment:

Drug: Vehicle