Study of Safety of RVL-1201 in Treatment of Blepharoptosis

NCT03536949 | Completed Phase 3 Results FDA Drug

• 1 other identifier: RVL-1201-203
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 35

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.

Conditions

Blepharoptosis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

RVL-1201 Ophthalmic Solution, 0.1%

EXPERIMENTAL

RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%

Drug: RVL-1201

Vehicle ophthalmic solution

PLACEBO COMPARATOR

Vehicle placebo ophthalmic solution

Other: Vehicle ophthalmic solution

Interventions

RVL-1201 DRUG

RVL-1201 ophthalmic solution, 0.1%

RVL-1201 Ophthalmic Solution, 0.1%

Vehicle ophthalmic solution OTHER

Vehicle placebo ophthalmic solution

Vehicle ophthalmic solution

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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 (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.

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

Sponsors & Collaborators

• RVL Pharmaceuticals, Inc.: lead

Study Sites (35)

Barnet, Dulany Perkins

Phoenix, Arizona, 85016, United States

Location

Orange County Ophthalmology Medical Group

Garden Grove, California, 92843, United States

Location

North Valley Eye Medical

Mission Hills, California, 91345, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Pendelton Eye Center

Oceanside, California, 92056, United States

Location

North Bay Eye Associates

Petaluma, California, 94954, United States

Location

Michael K. Tran, MD Inc.

Westminster, California, 92683, United States

Location

Danbury Eye Physicians and Surgeons

Danbury, Connecticut, 06810, United States

Location

Hernando Eye Institute

Brooksville, Florida, 34615, United States

Location

Shettle Eye Research

Largo, Florida, 33773, United States

Location

West Coast Eye Institute

Lecanto, Florida, 34461, United States

Location

Sabal Eye Care

Longwood, Florida, 32779, United States

Location

Maitland Vision Center

Maitland, Florida, 32751, United States

Location

Sarasota Retina Institute

Sarasota, Florida, 34239, United States

Location

East Florida Eye Institute

Stuart, Florida, 34994, United States

Location

Coastal Research Associates

Roswell, Georgia, 30076, United States

Location

Kennar Eye Care

Pittsburg, Kansas, 66762, United States

Location

Heart of America Eye Care

Shawnee Mission, Kansas, 66204, United States

Location

Seidenberg Protzko Eye Associates

Havre de Grace, Maryland, 21078, United States

Location

Mississippi Eye Associates

Ocean Springs, Mississippi, 39564, United States

Location

Silverstein Eye Centers

Kansas City, Missouri, 64133, United States

Location

Comprehensive Eye Care

Washington, Missouri, 63090, United States

Location

Rochester Ophthalmological Group

Rochester, New York, 14618, United States

Location

South Shore Eye Care

Wantagh, New York, 11793, United States

Location

CEENTA

Charlotte, North Carolina, 28210, United States

Location

Cornerstone Eye Care

High Point, North Carolina, 27262, United States

Location

Drs. Quinn, Foster & Associates

Athens, Ohio, 45701, United States

Location

Apex Eye

Cincinnati, Ohio, 45243, United States

Location

Apex Eye

Cincinnati, Ohio, 45247, United States

Location

Abrams Eye Center

Cleveland, Ohio, 44115, United States

Location

Nashville Vision Associates

Nashville, Tennessee, 37205, United States

Location

Round Rock Eye Consultants

Austin, Texas, 78681, United States

Location

Texan Eye / Keystone Research, Ltd.

Austin, Texas, 78731, United States

Location

Lake Travis Eye and Laser Center

Lakeway, Texas, 78734-5304, United States

Location

R & R Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Results Point of Contact

• Title: Senior Director of Clinical Operations
• Organization: RVL Pharmaceuticals, Inc.

mvelasco@osmotica.com

908-809-1423

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: May 25, 2018
• Study Start: June 20, 2018
• Primary Completion: March 14, 2019
• Study Completion: March 27, 2019
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-09

Locations

US (35)