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

Phase 3CompletedNCT03489941

Bausch & Lomb Incorporated65 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Allergic Conjunctivitis

Interventions

EM-100DRUG

Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.

Zaditor®DRUG

Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.

VehicleDRUG

Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Total Eye Care, PA

Memphis, Tennessee, United States

Outcomes

Primary Outcomes

Ocular Itching

Ocular itching scores were self-assessed by the participant using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no itching), 1.0 = Intermittent tickle sensation involving more than just the corner of the eye, 2.0 = Mild continuous itch without desire to rub, 3.0 = Severe itch with desire to rub, and 4.0 = Incapacitating itch with irresistible urge to rub.

Time frame: 3, 5 and 7 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1

Secondary Outcomes

Conjunctival Redness

The investigator assessed conjunctival redness scores using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no dilated blood vessels), 1 = Mild (slightly dilated blood vessels: pink color; can be quadrantal), 2 = Moderate (more apparent dilation, with redder color, involving majority of the vessel bed), 3 = Severe (numerous and obvious dilated blood vessels, with deep red color and no color, or less red with chemosis), and 4 = Extremely Severe (large, numerous, dilated blood vessels characterized by unusually severe deep red color regardless of chemosis and involving the entire vessel bed).

Time frame: 7, 15 and 20 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.