A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.
NCT ID: NCT02553772
Last Updated: 2017-11-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
242 participants
INTERVENTIONAL
2016-01-06
2016-09-09
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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OM3 Tear
Carboxymethylcellulose based eye drop \[Omega-3 (OM3) Tear\] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Carboxymethylcellulose Based Eye Drop
Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
REFRESH OPTIVE® ADVANCED
Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Carboxymethylcellulose Sodium 0.5%
Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Interventions
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Carboxymethylcellulose Based Eye Drop
Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Carboxymethylcellulose Sodium 0.5%
Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Visual acuity of at least 20/32 (while wearing glasses, if necessary).
Exclusion Criteria
* Herpes keratitis in the last 6 months
* Cataract surgery, laser-assisted in situ keratomileusis \[LASIK\], or photorefractive keratectomy, within the last 6 months
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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The Private Practice of Milton Hom, OD
Azusa, California, United States
Havana Research Institute LLC
Burbank, California, United States
Lugene Eye Institute
Glendale, California, United States
Eric M. White, OD, INC
San Diego, California, United States
Moyes Eye Center, PC
Kansas City, Missouri, United States
Ophthalmology Associates
St Louis, Missouri, United States
Rochester Ophthalmological Group, PC
Rochester, New York, United States
Charlotte Eye Ear Nose
Charlotte, North Carolina, United States
Scott and Christie and Associate
Cranberry Township, Pennsylvania, United States
Texan Eye
Austin, Texas, United States
Department of Optometry & Vision Sciences, The University of Melbourne
Parkville, , Australia
Prof. M.T. Coroneo Pty. Ltd.
Randwick, , Australia
The University of New South Wales School of Optometry and Vision Science
Sydney, , Australia
Countries
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Related Links
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More Information
Other Identifiers
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11182X-001
Identifier Type: -
Identifier Source: org_study_id