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

Allergic Conjunctivitis Clinical Trial

Official title:

A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle in the Treatment of Ocular Itching Associated With Allergic Conjunctivitis as Induced by the Conjunctival Allergen Challenge Model (Ora-CAC®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03489941
• Other study ID #: 17-100-0011
• Status: Completed
• Phase: Phase 3
• Start date: April 7, 2018
• Est. completion date: April 29, 2018

Study information

• Verified date: April 2021
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 29, 2018
• Est. primary completion date: April 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• EM-100
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
• Zaditor®
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
• Vehicle
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.

Locations

Country	Name	City	State
United States	Total Eye Care, PA	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated	ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3, 5 and 7 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1
Secondary	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).	7, 15 and 20 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1