CompletedPhase 1/2

Safety and Efficacy Study of RVL-1201 in Acquired Blepharoptosis

United States46 participantsStarted 2013-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adult male or female subjects 18 years of age and older.
✓. Presence of all of the following at Screening:
✓. Loss on HVF 36-point ptosis protocol test of ≥ 8 points in points not seen at or above 10° from fixation in the superior visual field; AND
✓. Marginal reflex distance (MRD), the distance from the central pupillary light reflex to the upper lid margin, of ≤ 2.5 mm in the same eye as Inclusion Criterion #2a; AND
✓. Corrected Snellen visual acuity (VA) of 20/40 or better (refraction must be within 6 months of Visit 1) in the same eye as Inclusion Criteria #2a and #2b.

Exclusion criteria

✕. Female subjects must be 1-year postmenopausal, surgically sterilized, or women of childbearing potential with a negative urine pregnancy test at Visit 1. Women of childbearing potential must use an acceptable form of contraception throughout the study.
✕. Provide informed consent prior to undergoing any study-related procedures.
✕. Congenital ptosis
✕. Pseudoptosis
✕. Horner syndrome
✕. Marcus Gunn jaw-winking syndrome
✕. Myasthenia gravis
✕. Mechanical ptosis, including ptosis due to orbital or lid tumor, cicatricial processes affecting the movements of the upper lid, and enophthalmos

What they're measuring

Humphrey Visual Field

Timeframe: Baseline (Day 0, Hour 0), Visit 4 (Day 13, Hour 2) and Visit 4 (Day 13, Hour 6)

Trial details

NCT IDNCT01848041

SponsorRVL Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-01

Results submitted2021-07-01

View on ClinicalTrials.gov More Blepharoptosis trials