A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle
NCT ID: NCT03489941
Last Updated: 2023-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
65 participants
INTERVENTIONAL
2018-04-07
2018-04-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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EM-100
One drop of EM-100 in either the right or left eye once on Day 1.
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®
One drop of Zaditor® in either the right or left eye once on Day 1.
Zaditor®
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
Vehicle
One drop of Vehicle in either the right or left eye once on Day 1.
Vehicle
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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ORA, Inc.
INDUSTRY
Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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Locations
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Total Eye Care, PA
Memphis, Tennessee, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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17-100-0011
Identifier Type: -
Identifier Source: org_study_id
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