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OpenTrials
Completed

NCT Number: NCT03565887

Study of Safety and Efficacy of RVL-1201 in the Treatment of 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.

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Key information

Conditions

Blepharoptosis Eye Diseases Eyelid Diseases

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Barnet, Dulany Perkins, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

RVL-1201

Drug

RVL-1201 ophthalmic solution 0.1%

Vehicle ophthalmic solution

Other

Vehicle placebo ophthalmic solution

Primary outcomes

  1. Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group

    Time frame: Mean change from Baseline (Day 1, Hour 0) compared with Day 1, (Hour 6), and Day 14 (Hour 2)

    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).

Secondary outcomes

  1. Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye

    Time frame: Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42

    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.

Sponsors and collaborators

Lead sponsor

RVL Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 21, 2018
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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