Study of Safety of RVL-1201 in Treatment of Blepharoptosis

September 15, 2020 updated by: RVL Pharmaceuticals, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
234

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Intraocular Pressure (IOP) at Day 84
Time Frame: Screening/Day 1 to 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
Time Frame: Screening/Day 1 to 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RVL Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 14, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 27, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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