Study of Safety of RVL-1201 in Treatment of Blepharoptosis

Blepharoptosis Clinical Trial

Official title:

A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Safety of RVL-1201 in the Treatment of Acquired Blepharoptosis (Study RVL-1201-203)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536949
• Other study ID #: RVL-1201-203
• Status: Completed
• Phase: Phase 3
• Start date: June 20, 2018
• Est. completion date: March 27, 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 extended safety of 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: 234
• Est. completion date: March 27, 2019
• Est. primary completion date: March 14, 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 (ICF). 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	Drs. Quinn, Foster & Associates	Athens	Ohio
United States	Round Rock Eye Consultants	Austin	Texas
United States	Texan Eye / Keystone Research, Ltd.	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 and Surgeons	Danbury	Connecticut
United States	Orange County Ophthalmology Medical Group	Garden Grove	California
United States	Seidenberg Protzko Eye Associates	Havre De Grace	Maryland
United States	Cornerstone Eye Care	High Point	North Carolina
United States	Silverstein Eye Centers	Kansas City	Missouri
United States	Lake Travis Eye and Laser Center	Lakeway	Texas
United States	Shettle Eye Research	Largo	Florida
United States	West Coast Eye Institute	Lecanto	Florida
United States	Sabal Eye Care	Longwood	Florida
United States	Maitland Vision Center	Maitland	Florida
United States	North Valley Eye Medical	Mission Hills	California
United States	Nashville Vision Associates	Nashville	Tennessee
United States	Eye Research Foundation	Newport Beach	California
United States	Mississippi Eye Associates	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 Group	Rochester	New York
United States	Coastal Research Associates	Roswell	Georgia
United States	R & R Research	San Antonio	Texas
United States	Sarasota Retina Institute	Sarasota	Florida
United States	Heart of America Eye Care	Shawnee Mission	Kansas
United States	East Florida Eye Institute	Stuart	Florida
United States	South Shore Eye Care	Wantagh	New York
United States	Comprehensive Eye Care	Washington	Missouri
United States	Michael K. Tran, MD Inc.	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 From Baseline in Intraocular Pressure (IOP) at Day 84	Intraocular pressure will be measured in mmHg utilizing a tonometer and using the standard of care. If possible, the same calibrated instrument should be used for a given subject throughout the study.	Screening/Day 1 to Day 84
Primary	Mean Change From Baseline in Pupil Diameter (PD) at Day 84	Pupil diameter will be measured in millimeters (either horizontally or vertically if top of pupil is not visible in photograph) from the external photograph.	Screening/Day 1 to Day 84