Study of Safety and Efficacy of RVL-1201 in the Treatment of Blepharoptosis
A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis
1 other identifier
interventional
164
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2018
Shorter than P25 for phase_3
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2018
CompletedFirst Posted
Study publicly available on registry
June 21, 2018
CompletedStudy Start
First participant enrolled
June 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2019
CompletedResults Posted
Study results publicly available
September 16, 2020
CompletedSeptember 16, 2020
September 1, 2020
10 months
April 11, 2018
August 4, 2020
September 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye
Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42
Study Arms (2)
RVL-1201 ophthalmic solution 0.1%
EXPERIMENTALRVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%
Vehicle ophthalmic solution
PLACEBO COMPARATORVehicle placebo ophthalmic solution
Interventions
Eligibility Criteria
You may qualify if:
- Male or Female 9 years of age or older
- Females must not be pregnant or planning to get pregnant and must use acceptable form of contraception
- Must be able to self-administer study medication
- 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.
You may not qualify if:
- Congenital ptosis
- Horner syndrome
- Myasthenia gravis
- Mechanical ptosis
- Previous ptosis surgery
- Resting heart rate outside the normal range
- Hypertension with resting diastolic blood pressure
- Pregnancy or lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Barnet, Dulany Perkins
Phoenix, Arizona, 85016, United States
Orange County Ophthalmology
Garden Grove, California, 92843, United States
North Valley Eye
Mission Hills, California, 941345, United States
Eye Research Foundation
Newport Beach, California, 92663, United States
Pendelton Eye Center
Oceanside, California, 92056, United States
North Bay Eye Associates
Petaluma, California, 94954, United States
Michael Tran
Westminster, California, 92683, United States
Danbury Eye Physicians
Danbury, Connecticut, 06810, United States
Hernando Eye Institute
Brooksville, Florida, 34615, United States
Shettle Eye Research
Largo, Florida, 33773, United States
West Coast Eye
Lecanto, Florida, 34461, United States
Sabal Eye Care
Longwood, Florida, 32779, United States
Maitland Vision Center
Maitland, Florida, 32751, United States
Sarasota Retina Institute
Sarasota, Florida, 34239, United States
East Florida Eye
Stuart, Florida, 34994, United States
Coastal Research Associates
Roswell, Georgia, 30076, United States
Kennar Eye Care
Pittsburg, Kansas, 66762, United States
Heart of America Eye
Shawnee Mission, Kansas, 66204, United States
Seidenberg Protzko Eye
Havre de Grace, Maryland, 21078, United States
Mississippi Eye
Ocean Springs, Mississippi, 39564, United States
Silverstein Eye
Kansas City, Missouri, 64133, United States
Comprehensive Eye Care
Washington, Missouri, 63090, United States
Rochester Ophthalmological
Rochester, New York, 14618, United States
South Shore Eye
Wantagh, New York, 11793, United States
CEENTA
Charlotte, North Carolina, 28210, United States
Cornerstone Eye
High Point, North Carolina, 27262, United States
Quinn, Foster & Assoc.
Athens, Ohio, 45701, United States
Apex Eye
Cincinnati, Ohio, 45243, United States
Apex Eye
Cincinnati, Ohio, 45247, United States
Abrams Eye Center
Cleveland, Ohio, 44115, United States
Nashville vision Associates
Nashville, Tennessee, 37205, United States
Round Rock Eye
Austin, Texas, 78681, United States
Texan Eye / Keystone
Austin, Texas, 78731, United States
Lake Travis Eye
Lakeway, Texas, 78734, United States
R&R Research
San Antonio, Texas, 78229, United States
Medical Center Ophthalmology Assocs - Keystone Research
San Antonio, Texas, 78240, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director of Clinical Operations
- Organization
- RVL Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2018
First Posted
June 21, 2018
Study Start
June 28, 2018
Primary Completion
April 11, 2019
Study Completion
April 22, 2019
Last Updated
September 16, 2020
Results First Posted
September 16, 2020
Record last verified: 2020-09