CompletedPhase 3

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

United States164 participantsStarted 2018-06-28

Plain-language summary

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.

Who can participate

Age range9 Years

SexALL

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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

What they're measuring

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

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

Trial details

NCT IDNCT03565887

SponsorRVL Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-04-11

Results submitted2020-08-04

View on ClinicalTrials.gov More Blepharoptosis trials