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

Phase 3

Completed

• Conditions: Blepharoptosis
• Interventions: Other: Vehicle ophthalmic solution; Drug: RVL-1201

• Registration Number: NCT03565887
• Lead Sponsor: RVL Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-06-20
• Study First Posted: 2018-06-21
• Study Start: 2018-06-28
• Primary Completion: 2019-04-11
• Study Completion: 2019-04-22
• Disposition First Submitted: 2020-04-28
• Results First Submitted: 2020-08-04
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-15
• Disposition First Submitted QC: 2020-09-15
• Last Update Submitted: 2020-09-15
• Results First Posted: 2020-09-16
• Disposition First Posted: 2020-09-16
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

1. Male or Female 9 years of age or older
2. Females must not be pregnant or planning to get pregnant and must use acceptable form of contraception
3. Must be able to self-administer study medication
4. 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

1. Congenital ptosis
2. Horner syndrome
3. Myasthenia gravis
4. Mechanical ptosis
5. Previous ptosis surgery
6. Resting heart rate outside the normal range
7. Hypertension with resting diastolic blood pressure
8. Pregnancy or lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle ophthalmic solution	Vehicle ophthalmic solution	Vehicle placebo ophthalmic solution
RVL-1201 ophthalmic solution 0.1%	RVL-1201	RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%

Primary Outcome Measures

Name	Time	Method
Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group	Mean change from Baseline (Day 1, Hour 0) compared with Day 1, (Hour 6), and Day 14 (Hour 2)	LPFT Total Score is the number of points seen in the top 4 rows on the LPFT. Possible scores range from 0 (no points seen) to 35 (all points seen).

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye	Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42	The Marginal Reflex Distance (MRD) is the distance from the center pupillary light reflex to the central margin of the upper eyelid. The MRD is measured from an external photograph using a handheld caliper and a millimeter ruler label placed on the subject's forehead as a measurement legend.

Trial Locations

Locations (35)

Barnet, Dulany Perkins; 🇺🇸 Phoenix, Arizona, United States

Orange County Ophthalmology; 🇺🇸 Garden Grove, California, United States

North Valley Eye; 🇺🇸 Mission Hills, California, United States

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States

Pendelton Eye Center; 🇺🇸 Oceanside, California, United States

North Bay Eye Associates; 🇺🇸 Petaluma, California, United States

Michael Tran; 🇺🇸 Westminster, California, United States

Danbury Eye Physicians; 🇺🇸 Danbury, Connecticut, United States

Hernando Eye Institute; 🇺🇸 Brooksville, Florida, United States

Shettle Eye Research; 🇺🇸 Largo, Florida, United States

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