Back to resultsA Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
EM-100
Zaditor®
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
Eligibility Criteria
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
Sites / Locations
- Total Eye Care, PA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
EM-100
Zaditor®
Vehicle
Arm Description
One drop of EM-100 in either the right or left eye once on Day 1.
One drop of Zaditor® in either the right or left eye once on Day 1.
One drop of Vehicle in either the right or left eye once on Day 1.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT03489941
First Posted
March 29, 2018
Last Updated
May 15, 2023
Sponsor
Bausch & Lomb Incorporated
Collaborators
ORA, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03489941
Brief Title
A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle
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®)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 7, 2018 (Actual)
Primary Completion Date
April 29, 2018 (Actual)
Study Completion Date
April 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
Collaborators
ORA, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the treatment of ocular itching.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EM-100
Arm Type
Experimental
Arm Description
One drop of EM-100 in either the right or left eye once on Day 1.
Arm Title
Zaditor®
Arm Type
Experimental
Arm Description
One drop of Zaditor® in either the right or left eye once on Day 1.
Arm Title
Vehicle
Arm Type
Experimental
Arm Description
One drop of Vehicle in either the right or left eye once on Day 1.
Intervention Type
Drug
Intervention Name(s)
EM-100
Intervention Description
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
Intervention Type
Drug
Intervention Name(s)
Zaditor®
Intervention Description
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
Primary Outcome Measure Information:
Title
Ocular Itching
Description
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 Outcome Measure Information:
Title
Conjunctival Redness
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Total Eye Care, PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle
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