Clinical trial NCT03565887: Study of Safety and Efficacy of RVL-1201 in the Treatment of Blepharoptosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blepharoptosis
Lead sponsor: RVL Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-21
Enrollment: 164
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group
timeFrame: Mean change from Baseline (Day 1, Hour 0) compared with Day 1, (Hour 6), and Day 14 (Hour 2)
Secondary outcomes:
measure: Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye
timeFrame: Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barnet, Dulany Perkins
state: Arizona
city: Garden Grove
country: United States
facility: Orange County Ophthalmology
state: California
city: Mission Hills
country: United States
facility: North Valley Eye
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Oceanside
country: United States
facility: Pendelton Eye Center
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: Westminster
country: United States
facility: Michael Tran
state: California
city: Danbury
country: United States
facility: Danbury Eye Physicians
state: Connecticut
city: Brooksville
country: United States
facility: Hernando Eye Institute
state: Florida
city: Largo
country: United States
facility: Shettle Eye Research
state: Florida
city: Lecanto
country: United States
facility: West Coast Eye
state: Florida
city: Longwood
country: United States
facility: Sabal Eye Care
state: Florida
city: Maitland
country: United States
facility: Maitland Vision Center
state: Florida
city: Sarasota
country: United States
facility: Sarasota Retina Institute
state: Florida
city: Stuart
country: United States
facility: East Florida Eye
state: Florida
city: Roswell
country: United States
facility: Coastal Research Associates
state: Georgia
city: Pittsburg
country: United States
facility: Kennar Eye Care
state: Kansas
city: Shawnee Mission
country: United States
facility: Heart of America Eye
state: Kansas
city: Havre De Grace
country: United States
facility: Seidenberg Protzko Eye
state: Maryland
city: Ocean Springs
country: United States
facility: Mississippi Eye
state: Mississippi
city: Kansas City
country: United States
facility: Silverstein Eye
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care
state: Missouri
city: Rochester
country: United States
facility: Rochester Ophthalmological
state: New York
city: Wantagh
country: United States
facility: South Shore Eye
state: New York
city: Charlotte
country: United States
facility: CEENTA
state: North Carolina
city: High Point
country: United States
facility: Cornerstone Eye
state: North Carolina
city: Athens
country: United States
facility: Quinn, Foster & Assoc.
state: Ohio
city: Cincinnati
country: United States
facility: Apex Eye
state: Ohio
city: Cincinnati
country: United States
facility: Apex Eye
state: Ohio
city: Cleveland
country: United States
facility: Abrams Eye Center
state: Ohio
city: Nashville
country: United States
facility: Nashville vision Associates
state: Tennessee
city: Austin
country: United States
facility: Round Rock Eye
state: Texas
city: Austin
country: United States
facility: Texan Eye / Keystone
state: Texas
city: Lakeway
country: United States
facility: Lake Travis Eye
state: Texas
city: San Antonio
country: United States
facility: R&R Research
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Assocs - Keystone Research
state: Texas
Study officials:
References: