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

Blepharoptosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565887
• Other study ID #: RVL-1201-202
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Blepharoptosis

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