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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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
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Largo, Florida
Phone: 727-674-2500
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Athens, Ohio 45701
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6035 Fairview Road
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Cincinnati, Ohio 45247
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Cleveland, Ohio 44115
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69 Sand Pit Road
Danbury, Connecticut 06810
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Garden Grove, California 92843
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Havre De Grace, Maryland 21078
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High Point, North Carolina 27262
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Kansas City, Missouri 64133
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Lecanto, Florida 34461
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105 East Lake Brantley Drive
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600 South Orlando Avenue
Maitland, Florida 32751
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Mission Hills, California 94134
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2521 North Broadway
Pittsburg, Kansas 66762
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Rochester, New York 14618
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Roswell, Georgia 30076
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