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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03489941
Other study ID # 17-100-0011
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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