To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease
NCT ID: NCT04747977
Last Updated: 2023-02-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
172 participants
INTERVENTIONAL
2021-02-12
2021-09-22
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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OTX-DED 0.2mg
Approximately 50 subjects
OTX-DED
0.2mg dexamethasone ophthalmic insert
OTX-DED 0.3mg
Approximately 50 subjects
OTX-DED
0.3mg dexamethasone ophthalmic insert
Hydrogel Vehicle (HV)
Approximately 50 subjects
OTX-DED
Hydrogel vehicle ophthalmic insert
Interventions
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OTX-DED
0.2mg dexamethasone ophthalmic insert
OTX-DED
0.3mg dexamethasone ophthalmic insert
OTX-DED
Hydrogel vehicle ophthalmic insert
Eligibility Criteria
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Inclusion Criteria
* VAS eye dryness severity score ≥ 40.
Exclusion Criteria
* Are unwilling to withhold use of artificial tears.
18 Years
ALL
No
Sponsors
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Ocular Therapeutix, Inc.
INDUSTRY
Responsible Party
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Locations
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Ocular Therapeutix
Inglewood, California, United States
Ocular Therapeutix, Inc
Mission Hills, California, United States
Ocular Therapeutix, Inc.
Newport Beach, California, United States
Ocular Therapeutix, Inc.
Santa Ana, California, United States
Ocular Therapeutix, Inc.
Delray Beach, Florida, United States
Ocular Therapeutix, Inc.
Largo, Florida, United States
Ocular Therapeutix
Warrenville, Illinois, United States
Ocular Therapeutix, Inc.
Indianapolis, Indiana, United States
Ocular Therapeutix
Kansas City, Missouri, United States
Ocular Therapeutix, Inc.
St Louis, Missouri, United States
Ocular Therapeutix
Poughkeepsie, New York, United States
Ocular Therapeutix, Inc.
Raleigh, North Carolina, United States
Ocular Therapeutix, Inc.
Cranberry Township, Pennsylvania, United States
Ocular Therapeutix, Inc.
Memphis, Tennessee, United States
Ocular Therapeutix, Inc.
League City, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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OTX-DED-2020-201
Identifier Type: -
Identifier Source: org_study_id
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