A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Safety of RVL-1201 in the Treatment of Acquired Blepharoptosis (Study RVL-1201-203)
Overview
- Phase
- Phase 3
- Intervention
- RVL-1201
- Conditions
- Blepharoptosis
- Sponsor
- RVL Pharmaceuticals, Inc.
- Enrollment
- 234
- Locations
- 34
- Primary Endpoint
- Mean Change From Baseline in Intraocular Pressure (IOP) at Day 84
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
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
Arms & Interventions
RVL-1201 Ophthalmic Solution, 0.1%
RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%
Intervention: RVL-1201
Vehicle ophthalmic solution
Vehicle placebo ophthalmic solution
Intervention: Vehicle ophthalmic solution
Outcomes
Primary Outcomes
Mean Change From Baseline in Intraocular Pressure (IOP) at Day 84
Time Frame: Screening/Day 1 to Day 84
Intraocular pressure will be measured in mmHg utilizing a tonometer and using the standard of care. If possible, the same calibrated instrument should be used for a given subject throughout the study.
Mean Change From Baseline in Pupil Diameter (PD) at Day 84
Time Frame: Screening/Day 1 to Day 84
Pupil diameter will be measured in millimeters (either horizontally or vertically if top of pupil is not visible in photograph) from the external photograph.