Clinical trial NCT03536949: Study of Safety of RVL-1201 in Treatment of Blepharoptosis
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blepharoptosis
Lead sponsor: RVL Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-25
Enrollment: 234
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 extended safety of 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 (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

Primary outcomes:
measure: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 84
timeFrame: Screening/Day 1 to Day 84
measure: Mean Change From Baseline in Pupil Diameter (PD) at Day 84
timeFrame: Screening/Day 1 to Day 84
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barnet, Dulany Perkins
state: Arizona
city: Garden Grove
country: United States
facility: Orange County Ophthalmology Medical Group
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical
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 K. Tran, MD Inc.
state: California
city: Danbury
country: United States
facility: Danbury Eye Physicians and Surgeons
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 Institute
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 Institute
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 Care
state: Kansas
city: Havre De Grace
country: United States
facility: Seidenberg Protzko Eye Associates
state: Maryland
city: Ocean Springs
country: United States
facility: Mississippi Eye Associates
state: Mississippi
city: Kansas City
country: United States
facility: Silverstein Eye Centers
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care
state: Missouri
city: Rochester
country: United States
facility: Rochester Ophthalmological Group
state: New York
city: Wantagh
country: United States
facility: South Shore Eye Care
state: New York
city: Charlotte
country: United States
facility: CEENTA
state: North Carolina
city: High Point
country: United States
facility: Cornerstone Eye Care
state: North Carolina
city: Athens
country: United States
facility: Drs. Quinn, Foster & Associates
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 Consultants
state: Texas
city: Austin
country: United States
facility: Texan Eye / Keystone Research, Ltd.
state: Texas
city: Lakeway
country: United States
facility: Lake Travis Eye and Laser Center
state: Texas
city: San Antonio
country: United States
facility: R & R Research
state: Texas
Study officials:
References: