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

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

Official Title: A Randomized, Double-Masked, Placebo-Controlled Phase 1/2a Study of the Efficacy and Safety of Two Dosing Regimens of RVL-1201 in the Treatment of Acquired Blepharoptosis

Brief Summary: This is an exploratory, proof of concept study to evaluate the safety and efficacy of RVL-1201 dosed once or twice daily for 14 days compared to a placebo (vehicle) control in patients with ptosis.

Detailed Summary:

This is an exploratory, proof-of-concept study. The objectives include establishing the efficacy and duration of effect of once daily (QD) or twice daily (BID) administration of RVL-1201 and the safety profile following 14 days of treatment in 72 subjects (24 per arm) with acquired blepharoptosis.

Efficacy will be assessed at each treatment visit by the Humphrey Visual Field 36-point ptosis protocol test, photographic measurement of marginal reflex distance, palpebral fissure distance and contrast sensitivity in the study eye only and Visual Acuity assessment in both eyes.

Safety assessments will include slit lamp examination/corneal fluorescein staining, pupil size measurement, ophthalmoscopy/ fundus examination, tonometry, visual acuity; urine pregnancy test (for women of childbearing potential only), vital signs (Heart Rate/Blood Pressure); and collection of adverse events. Subject rating of study medication comfort and assessment of ongoing tolerability will also be obtained.

Primary efficacy endpoint is the mean increase from baseline in points seen on the HVF 36-point ptosis protocol test at various timepoints according to a hierarchical analysis.

Analysis of exploratory endpoints will provide characterization of the efficacy and duration of effect of RVL-1201 with a variety of efficacy measures, as well as the potential additional effect of BID over QD dosing and safety profile of BID administration of RVL-1201. Exploratory endpoints will be analyzed by each regimen against placebo and between regimens and will include:

  • The change from baseline in HVF, MRD, PFD, VA, and CS.
  • The change from baseline in B
    Sponsor: RevitaLid Inc.

    Current Primary Outcome: Humphrey Visual Field [ Time Frame: 14 days ]

    The mean increase from baseline (Day 0, Hour 0) in number of points seen on the HVF 36-point ptosis protocol test at various times on Day 0 and Day 13 according to a pre-planned hierarchical analysis


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Marginal Reflex Distance [ Time Frame: 14 days ]
      The distance from the pupillary light reflex to the central margin of the upper eyelid is the MRD. The MRD will be measured from the external photograph using calipers and the millimeter ruler as the legend.
    • Palpebral Fissure Distance Measurement [ Time Frame: 14 days ]
      The PFD is the distance from the upper lid margin to the lower lid margin measured through the central visual axis. It will be measured from the external photograph using handheld calipers and the millimeter ruler as the legend.
    • Contrast Sensitivity [ Time Frame: 14 days ]
      The Pelli-Robson contrast sensitivity chart will be used at a distance of 1 meter.
    • Safety [ Time Frame: 14 days ]
      Assessment of the safety and tolerability of RVL-1201 compared to vehicle will include bilateral ophthalmic examinations (corrected Snellen VA, pupil diameter measurement, slit lamp examination (SLE)/corneal fluorescein (CF) staining, IOP tonometry, ophthalmoscopy/fundus exam), measurement of vital signs, and recording of adverse events.


    Original Secondary Outcome: Same as current

    Information By: RevitaLid Inc.

    Dates:
    Date Received: May 3, 2013
    Date Started: May 2013
    Date Completion:
    Last Updated: January 12, 2016
    Last Verified: January 2016