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

Phase 3

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: EM-100; Drug: Zaditor®; Drug: Vehicle

• Registration Number: NCT03489941
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-29
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-06
• Study Start: 2018-04-07
• Primary Completion: 2018-04-29
• Study Completion: 2018-04-29
• Disposition First Submitted: 2020-09-01
• Results First Submitted: 2021-03-29
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-23
• Disposition First Submitted QC: 2021-04-23
• Results First Posted: 2021-05-17
• Disposition First Posted: 2021-05-17
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EM-100	EM-100	One drop of EM-100 in either the right or left eye once on Day 1.
Zaditor®	Zaditor®	One drop of Zaditor® in either the right or left eye once on Day 1.
Vehicle	Vehicle	One drop of Vehicle in either the right or left eye once on Day 1.

Primary Outcome Measures

Name	Time	Method
Ocular Itching	3, 5 and 7 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1	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.

Secondary Outcome Measures

Name	Time	Method
Conjunctival Redness	7, 15 and 20 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1	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).

Trial Locations

Locations (1)

Total Eye Care, PA; 🇺🇸 Memphis, Tennessee, United States