Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis
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|ClinicalTrials.gov Identifier: NCT02436759|
Recruitment Status : Completed
First Posted : May 7, 2015
Results First Posted : October 20, 2020
Last Update Posted : October 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acquired Blepharoptosis||Drug: RVL-1201 Drug: RVL-1201 Vehicle Placebo||Phase 3|
Ptosis is experienced by approximately 12% of adults over the age of 50 . It is a unilateral or bilateral abnormal drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscle(s) that elevate the upper eyelid: the levator palpebrae superioris and/or Müller's muscle.
Treatment for acquired ptosis usually involves surgery, with risks of infection, bleeding, over or undercorrection, reduced vision, and lagophthalmos (inability to close the eyelids completely) or mechanical treatment e.g scleral contact lenses with a bar to lift the eyelid, eyelid ptosis crutches attached to glasses, or adhesive tape or putty to affix the upper eyelid to the supraorbital structures.
RVL-201 ophthalmic solution is being developed to provide a reversible pharmacologic option for patients with acquired ptosis who are not candidates for surgery or do not wish to undergo surgery.
The objective of this study is to evaluate the safety and efficacy of RVL-1201 ophthalmic solution in the treatment of acquired blepharoptosis and to assess the safety and comfort of RVL-1201 ophthalmic solution for an extended dosing period of 6 weeks. Subjects will be randomized (2:1) to one of 2 treatment arms and treated for 42 days:
- RVL-1201 0.1% one full drop in each eye QD in the morning (N = 100)
- RVL-1201 vehicle (placebo) 1 full drop per eye QD in the morning (N = 50)
Efficacy will be assessed with the LPFT, a validated visual field test using the HVF Analyzer and photographic measurement of MRD (the distance from the pupillary light reflex to the central margin of the upper lid) and PFD (the distance from the upper lid margin to the lower lid margin through the central visual axis). Safety assessment will include bilateral SLE/CFS, measurement of PD from external photographs, dilated ophthalmoscopy/fundus examination, tonometry, Snellen VA using recent correction, vital signs (BP/HR), and collection of adverse events (AEs).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
RVL-1201 Ophthalmic Solution 0.1% 1 drop per eye QD for 6 weeks
RVL-1201 Ophthalmic Solution 0.1%
Other Name: Oxymetazoline Hydrochloride Ophthalmic Solution 0.1%
Placebo Comparator: RVL-1201 Vehicle Placebo
RVL-1201 Ophthalmic Solution vehicle (placebo) 1 drop per eye QD for 6 weeks
Drug: RVL-1201 Vehicle Placebo
RVL-1201 Vehicle Placebo
Other Name: RVL-1201 Ophthalmic Solution 0.1% Placebo
- Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group [ Time Frame: 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).
- Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye [ Time Frame: Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02436759
|United States, California|
|Artesia, California, United States|
|Newport Beach, California, United States|
|Rancho Cordova, California, United States|
|Santa Maria, California, United States|
|United States, Florida|
|Fort Myers, Florida, United States|
|Largo, Florida, United States|
|Plantation, Florida, United States|
|Sarasota, Florida, United States|
|United States, Georgia|
|Roswell, Georgia, United States|
|United States, Kansas|
|Pittsburg, Kansas, United States|
|Shawnee Mission, Kansas, United States|
|United States, Ohio|
|Mason, Ohio, United States|
|United States, Pennsylvania|
|Kingston, Pennsylvania, United States|
|United States, Tennessee|
|Nashville, Tennessee, United States|