Study of Safety of RVL-1201 in Treatment of Blepharoptosis

Phase 3

Completed

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

• Registration Number: NCT03536949
• Lead Sponsor: RVL Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-05-23
• Study First Posted: 2018-05-25
• Study Start: 2018-06-20
• Primary Completion: 2019-03-14
• Study Completion: 2019-03-27
• Disposition First Submitted: 2020-04-28
• Results First Submitted: 2020-08-06
• 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: 234

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 (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

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
RVL-1201 Ophthalmic Solution, 0.1%	RVL-1201	RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%
Vehicle ophthalmic solution	Vehicle ophthalmic solution	Vehicle placebo ophthalmic solution

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Intraocular Pressure (IOP) at Day 84	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	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.

Trial Locations

Locations (34)

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

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

North Valley Eye Medical; 🇺🇸 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 K. Tran, MD Inc.; 🇺🇸 Westminster, California, United States

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

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

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

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