Phase 3 N=234 Randomized Triple-blind Treatment

Study of Safety of RVL-1201 in Treatment of Blepharoptosis

Blepharoptosis

Bottom Line

View on ClinicalTrials.gov: NCT03536949 ↗

Enrolled (actual)

234

Serious AEs

0.9%

Results posted

Sep 2020

Primary outcome: Primary: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 84 — -0.6; -0.2; -0.6; -0.2 mmHg

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: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Intraocular Pressure (IOP) at Day 84	-0.6; -0.2; -0.6; -0.2	—
PRIMARY Mean Change From Baseline in Pupil Diameter (PD) at Day 84	0.0; -0.1; 0.0; -0.1	—

Summary

Phase 3 study to evaluate the extended safety of 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 (ICF). 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03536949). 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.