Clinical Trial: Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: This is a Phase 3 study is to evaluate the safety and efficacy of RVL-1201 Ophthalmic Solution in the treatment of acquired blepharoptosis (ptosis) and to assess the safety and comfort of RVL-1201 Ophthalmic Solution for an extended dosing period of 6 weeks.

Detailed Summary:

Ptosis is experienced by approximately 12% of adults over the age of 50 . It is a unilateral or bilateral abnormal drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscle(s) that elevate the upper eyelid: the levator palpebrae superioris and/or Müller's muscle.

Treatment for acquired ptosis usually involves surgery, with risks of infection, bleeding, over or undercorrection, reduced vision, and lagophthalmos (inability to close the eyelids completely) or mechanical treatment e.g scleral contact lenses with a bar to lift the eyelid, eyelid ptosis crutches attached to glasses, or adhesive tape or putty to affix the upper eyelid to the supraorbital structures.

RVL-201 ophthalmic solution is being developed to provide a reversible pharmacologic option for patients with acquired ptosis who are not candidates for surgery or do not wish to undergo surgery.

The objective of this study is to evaluate the safety and efficacy of RVL-1201 ophthalmic solution in the treatment of acquired blepharoptosis and to assess the safety and comfort of RVL-1201 ophthalmic solution for an extended dosing period of 6 weeks. Subjects will be randomized (2:1) to one of 2 treatment arms and treated for 42 days:

  • RVL-1201 0.1% one full drop in each eye QD in the morning (N = 100)
  • RVL-1201 vehicle (placebo) 1 full drop per eye QD in the morning (N = 50)

Efficacy will be assessed with the LPFT, a validated visual field test using the HVF Analyzer and photographic measurement of MRD (the distance from the pupillary light reflex to the central margin of the upper lid) and PFD (the distan
Sponsor: RevitaLid Inc.

Current Primary Outcome:

  • Visual Field [ Time Frame: 6 hours ]
    Mean increase from baseline in number of points seen on the LPFT at Hour 6 on Day 1
  • Visual Field [ Time Frame: 14 Days ]
    Mean increase from baseline in number of points seen on the LPFT at Hour 2 on Day 14


Original Primary Outcome: Same as current

Current Secondary Outcome: Safety as measured by an evaluation of adverse events [ Time Frame: 6 weeks ]

Evaluation of the incidence of adverse events


Original Secondary Outcome: Same as current

Information By: RevitaLid Inc.

Dates:
Date Received: May 4, 2015
Date Started: May 2015
Date Completion:
Last Updated: December 6, 2016
Last Verified: December 2016