Study of Safety of RVL-1201 in Treatment of Blepharoptosis

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)

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 234
• 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 Medical Group
    • Mission Hills, California, United States, 91345
      • North Valley Eye Medical
    • 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 K. Tran, MD Inc.
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Danbury Eye Physicians and Surgeons
  • 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 Institute
    • 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 Institute
  • 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 Care
  • Maryland
    • Havre De Grace, Maryland, United States, 21078
      • Seidenberg Protzko Eye Associates
  • Mississippi
    • Ocean Springs, Mississippi, United States, 39564
      • Mississippi Eye Associates
  • Missouri
    • Kansas City, Missouri, United States, 64133
      • Silverstein Eye Centers
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care
  • New York
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmological Group
    • Wantagh, New York, United States, 11793
      • South Shore Eye Care
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • CEENTA
    • High Point, North Carolina, United States, 27262
      • Cornerstone Eye Care
  • Ohio
    • Athens, Ohio, United States, 45701
      • Drs. Quinn, Foster & Associates
    • 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 Consultants
    • Austin, Texas, United States, 78731
      • Texan Eye / Keystone Research, Ltd.
    • Lakeway, Texas, United States, 78734-5304
      • Lake Travis Eye and Laser Center
    • San Antonio, Texas, United States, 78229
      • R & R 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 (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

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
Experimental: RVL-1201 Ophthalmic Solution, 0.1%; RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%	Drug: RVL-1201; RVL-1201 ophthalmic solution, 0.1%
Placebo Comparator: Vehicle ophthalmic solution; Vehicle placebo ophthalmic solution	Other: Vehicle ophthalmic solution; Vehicle placebo ophthalmic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: RVL Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2018
• Primary Completion (Actual): March 14, 2019
• Study Completion (Actual): March 27, 2019

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): May 25, 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-1201-203

Drug and device information, study documents

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