A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis
Overview
- Phase
- Phase 3
- Intervention
- RVL-1201
- Conditions
- Acquired Blepharoptosis
- Sponsor
- RVL Pharmaceuticals, Inc.
- Enrollment
- 140
- Primary Endpoint
- Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a Phase 3 study is to evaluate the safety and efficacy of RVL-1201 Ophthalmic Solution in the treatment of acquired blepharoptosis (ptosis) and to assess the safety and comfort of RVL-1201 Ophthalmic Solution for an extended dosing period of 6 weeks.
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects 18 years of age and older.
- •Presence of all of the following at Screening :
- •a. Loss on a reliable LPFT of ≥ 8 points in the top 2 rows (LPFT Eligibility Score); subjects must see at least 9 total points in the top 4 rows (LPFT Total Score).
- •i. This criteria must be met at both the Visit 1 Hour 0 (V1H0) and Visit 1 Hour 6 (V1H6) LPFT assessments
- •ii. There must be ≤ 4 points of variance between the V1H0 and the V1H6 LPFT Eligibility Score;; AND
- •b. The MRD, the distance from the central pupillary light reflex to the central margin of the upper lid, must be ≤ 2 mm (no visible central pupillary light reflex defaults to 0) in the same eye as Inclusion Criterion #2a
- •c. Snellen visual acuity (VA) of 20/80 or better in the same eye as Inclusion Criteria #2a and #2b.
- •Presence of all of the following at Baseline:
- •a. Loss on a reliable LPFT of ≥ 8 points in the top 2 rows (LPFT Eligibility Score) in the same eye as Inclusion Criterion #2a; subjects must see at least 9 total points in the top 4 rows (LPFT Total Score).
- •i. This criteria must be met at the Visit 2 Hour 0 (V2H0) LPFT assessment. ii. There must be ≤ 4 points of variance between the V1H6 and the V2H0 LPFT Eligibility Score;
Exclusion Criteria
- •In either eye
- •Congenital ptosis.
- •Presence of either of the following:
- •Pseudoptosis (upper eyelid dermatochalasis that overhangs the upper eyelid margin) or
- •Dermatochalasis that extends less than 3 mm above the upper eyelid margin.
- •Horner syndrome.
- •Marcus Gunn jaw winking syndrome.
- •Myasthenia gravis.
- •Mechanical ptosis, including ptosis due to orbital or lid tumor, cicatricial processes affecting the movements of the upper lid, and enophthalmos.
- •Previous ptosis surgery (previous blepharoplasty \[only\] is allowed provided the surgery took place \> 3 months prior to Visit 1).
Arms & Interventions
RVL-1201
RVL-1201 Ophthalmic Solution 0.1% 1 drop per eye QD for 6 weeks
Intervention: RVL-1201
RVL-1201 Vehicle Placebo
RVL-1201 Ophthalmic Solution vehicle (placebo) 1 drop per eye QD for 6 weeks
Intervention: RVL-1201 Vehicle Placebo
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- 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)