Study of Safety and Efficacy of RVL-1201 in the Treatment of Blepharoptosis



Status:Recruiting
Healthy:No
Age Range:9 - Any
Updated:2/14/2019
Start Date:June 28, 2018
End Date:February 28, 2019
Contact:Roselyn Judd
Email:rjudd@pointguardllc.com
Phone:586-212-0237

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Trial Summary
Trial Overview
Inclusion Criteria

A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis

Phase 3 study to evaluate the safety and efficacy of treatment with RVL-1201 compared to
placebo for treatment of blepharoptosis. Eligible subjects will be randomized to one of 2
treatment arms.


Inclusion Criteria:

1. - Male or Female 9 years of age or older

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:

1. - Congenital ptosis

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
We found this trial at
35
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Quinn, Foster & Assoc.
Athens, Ohio 45701
Phone: 740-594-2271
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Round Rock Eye
Austin, Texas 78681
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Texan Eye / Keystone
Austin, Texas 78731
Phone: 512-314-1653
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Hernando Eye Institute
Brooksville, Florida 34613
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CEENTA
6035 Fairview Road
Charlotte, North Carolina 28210
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Apex Eye
Cincinnati, Ohio 45247
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Abrams Eye Center
Cleveland, Ohio 44115
Phone: 216-937-2020
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Danbury Eye Physicians
69 Sand Pit Road
Danbury, Connecticut 06810
Phone: 203-791-2020
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Orange County Ophthalmology
Garden Grove, California 92843
Phone: 714-534-8373
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Seidenberg Protzko Eye
Havre De Grace, Maryland 21078
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Cornerstone Eye
High Point, North Carolina 27262
Phone: 336-802-2255
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Silverstein Eye
Kansas City, Missouri 64133
Phone: 816-595-3957
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Lake Travis Eye
Lakeway, Texas 78734
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Shettle Eye Research
Largo, Florida
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West Coast Eye
Lecanto, Florida 34461
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Sabal Eye Care
105 East Lake Brantley Drive
Longwood, Florida 32779
Phone: 407-869-4766
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Maitland Vision Center
600 South Orlando Avenue
Maitland, Florida 32751
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North Valley Eye
Mission Hills, California 94134
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Nashville Vision Associates
Nashville, Tennessee 37205
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Eye Research Foundation
Newport Beach, California
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Mississippi Eye
Ocean Springs, Mississippi 39564
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Pendelton Eye Center
3637 Vista Way
Oceanside, California 92056
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North Bay Eye Associates
Petaluma, California 94954
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Barnet, Dulany Perkins
4800 North 22nd Street
Phoenix, Arizona 85016
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Kennar Eye Care
2521 North Broadway
Pittsburg, Kansas 66762
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Rochester Ophthalmological
Rochester, New York 14618
Phone: 585-244-6011
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Coastal Research Associates, LLC
Roswell, Georgia 30076
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R&R Research
7979 Wurzbach Road
San Antonio, Texas 78229
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Medical Center Ophthalmology Assocs - Keystone Research
San Antonio, Texas 78240
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Sarasota Retina Institute
Sarasota, Florida 34239
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Heart of America Eye
Shawnee Mission, Kansas 66204
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East Florida Eye
Stuart, Florida 34994
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South Shore Eye
Wantagh, New York 11793
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Comprehensive Eye Care Ltd
Washington, Missouri
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Michael Tran
Westminster, California 92683
Phone: 714-839-2077
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