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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03565887
Other study ID # RVL-1201-202
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 28, 2018
Est. completion date April 22, 2019

Study information

Verified date September 2020
Source RVL Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 164
Est. completion date April 22, 2019
Est. primary completion date April 11, 2019
Accepts healthy volunteers No
Gender All
Age group 9 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
RVL-1201
RVL-1201 ophthalmic solution 0.1%
Other:
Vehicle ophthalmic solution
Vehicle placebo ophthalmic solution

Locations

Country Name City State
United States Quinn, Foster & Assoc. Athens Ohio
United States Round Rock Eye Austin Texas
United States Texan Eye / Keystone Austin Texas
United States Hernando Eye Institute Brooksville Florida
United States CEENTA Charlotte North Carolina
United States Apex Eye Cincinnati Ohio
United States Apex Eye Cincinnati Ohio
United States Abrams Eye Center Cleveland Ohio
United States Danbury Eye Physicians Danbury Connecticut
United States Orange County Ophthalmology Garden Grove California
United States Seidenberg Protzko Eye Havre De Grace Maryland
United States Cornerstone Eye High Point North Carolina
United States Silverstein Eye Kansas City Missouri
United States Lake Travis Eye Lakeway Texas
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 North Valley Eye Mission Hills California
United States Nashville vision Associates Nashville Tennessee
United States Eye Research Foundation Newport Beach California
United States Mississippi Eye Ocean Springs Mississippi
United States Pendelton Eye Center Oceanside California
United States North Bay Eye Associates Petaluma California
United States Barnet, Dulany Perkins Phoenix Arizona
United States Kennar Eye Care Pittsburg Kansas
United States Rochester Ophthalmological Rochester New York
United States Coastal Research Associates Roswell Georgia
United States Medical Center Ophthalmology Assocs - Keystone Research San Antonio Texas
United States R&R Research San Antonio Texas
United States Sarasota Retina Institute Sarasota Florida
United States Heart of America Eye Shawnee Mission Kansas
United States East Florida Eye Stuart Florida
United States South Shore Eye Wantagh New York
United States Comprehensive Eye Care Washington Missouri
United States Michael Tran Westminster California

Sponsors (1)

Lead Sponsor Collaborator
RVL Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group LPFT Total Score is the number of points seen in the top 4 rows on the LPFT. Possible scores range from 0 (no points seen) to 35 (all points seen). Mean change from Baseline (Day 1, Hour 0) compared with Day 1, (Hour 6), and Day 14 (Hour 2)
Secondary Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye The Marginal Reflex Distance (MRD) is the distance from the center pupillary light reflex to the central margin of the upper eyelid. The MRD is measured from an external photograph using a handheld caliper and a millimeter ruler label placed on the subject's forehead as a measurement legend. Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42
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