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

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.

Study Overview

• Status: Completed
• Conditions: Blepharoptosis
• Intervention / Treatment: Other: Vehicle ophthalmic solution; Drug: RVL-1201

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Barnet, Dulany Perkins
  • California
    • Garden Grove, California, United States, 92843
      • Orange County Ophthalmology
    • Mission Hills, California, United States, 941345
      • North Valley Eye
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
    • Oceanside, California, United States, 92056
      • Pendelton Eye Center
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates
    • Westminster, California, United States, 92683
      • Michael Tran
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Danbury Eye Physicians
  • Florida
    • Brooksville, Florida, United States, 34615
      • Hernando Eye Institute
    • Largo, Florida, United States, 33773
      • Shettle Eye Research
    • Lecanto, Florida, United States, 34461
      • West Coast Eye
    • Longwood, Florida, United States, 32779
      • Sabal Eye Care
    • Maitland, Florida, United States, 32751
      • Maitland Vision Center
    • Sarasota, Florida, United States, 34239
      • Sarasota Retina Institute
    • Stuart, Florida, United States, 34994
      • East Florida Eye
  • Georgia
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kennar Eye Care
    • Shawnee Mission, Kansas, United States, 66204
      • Heart of America Eye
  • Maryland
    • Havre De Grace, Maryland, United States, 21078
      • Seidenberg Protzko Eye
  • Mississippi
    • Ocean Springs, Mississippi, United States, 39564
      • Mississippi Eye
  • Missouri
    • Kansas City, Missouri, United States, 64133
      • Silverstein Eye
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care
  • New York
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmological
    • Wantagh, New York, United States, 11793
      • South Shore Eye
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • CEENTA
    • High Point, North Carolina, United States, 27262
      • Cornerstone Eye
  • Ohio
    • Athens, Ohio, United States, 45701
      • Quinn, Foster & Assoc.
    • Cincinnati, Ohio, United States, 45247
      • Apex Eye
    • Cincinnati, Ohio, United States, 45243
      • Apex Eye
    • Cleveland, Ohio, United States, 44115
      • Abrams Eye Center
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Nashville Vision Associates
  • Texas
    • Austin, Texas, United States, 78681
      • Round Rock Eye
    • Austin, Texas, United States, 78731
      • Texan Eye / Keystone
    • Lakeway, Texas, United States, 78734
      • Lake Travis Eye
    • San Antonio, Texas, United States, 78229
      • R&R Research
    • San Antonio, Texas, United States, 78240
      • Medical Center Ophthalmology Assocs - Keystone Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle ophthalmic solution; Vehicle placebo ophthalmic solution	Other: Vehicle ophthalmic solution; Vehicle placebo ophthalmic solution
Experimental: RVL-1201 ophthalmic solution 0.1%; RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%	Drug: RVL-1201; RVL-1201 ophthalmic solution 0.1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: RVL Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Actual): April 11, 2019
• Study Completion (Actual): April 22, 2019

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): June 21, 2018

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharoptosis; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: RVL-1201-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No