Phase 3
N=164
Study of Safety and Efficacy of RVL-1201 in the Treatment of Blepharoptosis
Blepharoptosis
Bottom Line
View on ClinicalTrials.gov: NCT03565887 ↗Enrolled (actual)
164
Serious AEs
1.2%
Results posted
Sep 2020
Primary outcome: Primary: Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group — 6.3; 2.1; 7.7; 2.4 Points seen — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- RVL-1201 (Drug); Vehicle ophthalmic solution (Other)
- Age
- Pediatric, Adult, Older Adult · 9+ yrs
- Sex
- All
- Sponsor
- RVL Pharmaceuticals, Inc.
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group |
6.3; 2.1; 7.7; 2.4 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye |
0.59; 0.20; 0.93; 0.32; 1.05; 0.33 | <0.0151 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03565887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.