Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3
NCT ID: NCT03937882
Last Updated: 2022-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
700 participants
INTERVENTIONAL
2019-05-24
2021-10-07
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
QUADRUPLE
Study Groups
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RGN-259
RGN-259: It is a preservative-free, sterile eye drop solution containing Thymosin beta 4
RGN-259
A preservative-free, sterile eye drop solution containing Thymosin beta 4 for direct instillation into each eye, four times a day (QID) for 14 days
Placebo
It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4
Placebo
It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4
Interventions
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RGN-259
A preservative-free, sterile eye drop solution containing Thymosin beta 4 for direct instillation into each eye, four times a day (QID) for 14 days
Placebo
It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Provide written informed consent;
* Have a subject reported history of dry eye for at least 6 months;
* Have a history of use or desire to use eye drops for dry eye symptoms within 6 months
Exclusion Criteria
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
* Have an uncontrolled systemic disease;
* Be a woman who is pregnant, nursing or planning a pregnancy
18 Years
ALL
No
Sponsors
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ReGenTree, LLC
INDUSTRY
Responsible Party
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Locations
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Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, United States
Eye Research Foundation
Newport Beach, California, United States
Vision Institute
Colorado Springs, Colorado, United States
Dovilan Wyatt MD, LLC
Chicago, Illinois, United States
Whitson Vision
Indianapolis, Indiana, United States
Midwest Cornea Associates, LLC
Indianapolis, Indiana, United States
The Eye Care Institute
Louisville, Kentucky, United States
Andover Eye Associates
Andover, Massachusetts, United States
Andover Eye Associates
Raynham, Massachusetts, United States
Center For Sight
Henderson, Nevada, United States
Oculus Research, Inc. at the Eye Care Center
Raleigh, North Carolina, United States
Visual Eyes Optometric
Shelby, North Carolina, United States
Bergstrom Eye Research, LLC
Fargo, North Dakota, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States
Andover Eye Associates
Warwick, Rhode Island, United States
Total Eye Care, P.A.
Memphis, Tennessee, United States
Texan Eye/Keystone Research
Austin, Texas, United States
Mountain View Eye Center
Layton, Utah, United States
Country Hills Eye Center
Ogden, Utah, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Countries
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Other Identifiers
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RGN-259/19-110-0002
Identifier Type: -
Identifier Source: org_study_id
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