Study of Safety and Efficacy of RVL-1201 in the Treatment of Blepharoptosis
NCT ID: NCT03565887
Last Updated: 2020-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
164 participants
INTERVENTIONAL
2018-06-28
2019-04-22
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
TRIPLE
Study Groups
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RVL-1201 ophthalmic solution 0.1%
RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%
RVL-1201
RVL-1201 ophthalmic solution 0.1%
Vehicle ophthalmic solution
Vehicle placebo ophthalmic solution
Vehicle ophthalmic solution
Vehicle placebo ophthalmic solution
Interventions
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RVL-1201
RVL-1201 ophthalmic solution 0.1%
Vehicle ophthalmic solution
Vehicle placebo ophthalmic solution
Eligibility Criteria
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Inclusion Criteria
2. Females must not be pregnant or planning to get pregnant and must use acceptable form of contraception
3. Must be able to self-administer study medication
4. Must be able to understand and sign an informed consent form. For minor subjects, the subject's parent or legal guardian must provide permission by signing an ICF on behalf of the subject and the subject should provide assent.
Exclusion Criteria
2. Horner syndrome
3. Myasthenia gravis
4. Mechanical ptosis
5. Previous ptosis surgery
6. Resting heart rate outside the normal range
7. Hypertension with resting diastolic blood pressure
8. Pregnancy or lactation
9 Years
ALL
No
Sponsors
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RVL Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Barnet, Dulany Perkins
Phoenix, Arizona, United States
Orange County Ophthalmology
Garden Grove, California, United States
North Valley Eye
Mission Hills, California, United States
Eye Research Foundation
Newport Beach, California, United States
Pendelton Eye Center
Oceanside, California, United States
North Bay Eye Associates
Petaluma, California, United States
Michael Tran
Westminster, California, United States
Danbury Eye Physicians
Danbury, Connecticut, United States
Hernando Eye Institute
Brooksville, Florida, United States
Shettle Eye Research
Largo, Florida, United States
West Coast Eye
Lecanto, Florida, United States
Sabal Eye Care
Longwood, Florida, United States
Maitland Vision Center
Maitland, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
East Florida Eye
Stuart, Florida, United States
Coastal Research Associates
Roswell, Georgia, United States
Kennar Eye Care
Pittsburg, Kansas, United States
Heart of America Eye
Shawnee Mission, Kansas, United States
Seidenberg Protzko Eye
Havre de Grace, Maryland, United States
Mississippi Eye
Ocean Springs, Mississippi, United States
Silverstein Eye
Kansas City, Missouri, United States
Comprehensive Eye Care
Washington, Missouri, United States
Rochester Ophthalmological
Rochester, New York, United States
South Shore Eye
Wantagh, New York, United States
CEENTA
Charlotte, North Carolina, United States
Cornerstone Eye
High Point, North Carolina, United States
Quinn, Foster & Assoc.
Athens, Ohio, United States
Apex Eye
Cincinnati, Ohio, United States
Apex Eye
Cincinnati, Ohio, United States
Abrams Eye Center
Cleveland, Ohio, United States
Nashville vision Associates
Nashville, Tennessee, United States
Round Rock Eye
Austin, Texas, United States
Texan Eye / Keystone
Austin, Texas, United States
Lake Travis Eye
Lakeway, Texas, United States
R&R Research
San Antonio, Texas, United States
Medical Center Ophthalmology Assocs - Keystone Research
San Antonio, 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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RVL-1201-202
Identifier Type: -
Identifier Source: org_study_id
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