Safety and Efficacy Study of RVL-1201 in Acquired Blepharoptosis
This is an exploratory, proof of concept study to evaluate the safety and efficacy of RVL-1201 dosed once or twice daily for 14 days compared to a placebo (vehicle) control in patients with ptosis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Masked, Placebo-Controlled Phase 1/2a Study of the Efficacy and Safety of Two Dosing Regimens of RVL-1201 in the Treatment of Acquired Blepharoptosis|
- Humphrey Visual Field [ Time Frame: 14 days ] [ Designated as safety issue: No ]The mean increase from baseline (Day 0, Hour 0) in number of points seen on the HVF 36-point ptosis protocol test at various times on Day 0 and Day 13 according to a pre-planned hierarchical analysis
- Marginal Reflex Distance [ Time Frame: 14 days ] [ Designated as safety issue: No ]The distance from the pupillary light reflex to the central margin of the upper eyelid is the MRD. The MRD will be measured from the external photograph using calipers and the millimeter ruler as the legend.
- Palpebral Fissure Distance Measurement [ Time Frame: 14 days ] [ Designated as safety issue: No ]The PFD is the distance from the upper lid margin to the lower lid margin measured through the central visual axis. It will be measured from the external photograph using handheld calipers and the millimeter ruler as the legend.
- Contrast Sensitivity [ Time Frame: 14 days ] [ Designated as safety issue: No ]The Pelli-Robson contrast sensitivity chart will be used at a distance of 1 meter.
- Safety [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]Assessment of the safety and tolerability of RVL-1201 compared to vehicle will include bilateral ophthalmic examinations (corrected Snellen VA, pupil diameter measurement, slit lamp examination (SLE)/corneal fluorescein (CF) staining, IOP tonometry, ophthalmoscopy/fundus exam), measurement of vital signs, and recording of adverse events.
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: RVL-1201 once daily
RVL-1201 0.1% ophthalmic solution dosed one full drop per eye in the morning; one full drop of vehicle (placebo) per eye approximately 8 hours after the morning dose
RVL-1201 0.1% Ophthalmic Solution
Experimental: RVL-1201 twice daily
RVL-1201 0.1% ophthalmic solution dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose
RVL-1201 0.1% Ophthalmic Solution
Placebo Comparator: RVL-1201 vehicle (placebo)
RVL 1201 ophthalmic solution vehicle (placebo) dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose
This is an exploratory, proof-of-concept study. The objectives include establishing the efficacy and duration of effect of once daily (QD) or twice daily (BID) administration of RVL-1201 and the safety profile following 14 days of treatment in 72 subjects (24 per arm) with acquired blepharoptosis.
Efficacy will be assessed at each treatment visit by the Humphrey Visual Field 36-point ptosis protocol test, photographic measurement of marginal reflex distance, palpebral fissure distance and contrast sensitivity in the study eye only and Visual Acuity assessment in both eyes.
Safety assessments will include slit lamp examination/corneal fluorescein staining, pupil size measurement, ophthalmoscopy/ fundus examination, tonometry, visual acuity; urine pregnancy test (for women of childbearing potential only), vital signs (Heart Rate/Blood Pressure); and collection of adverse events. Subject rating of study medication comfort and assessment of ongoing tolerability will also be obtained.
Primary efficacy endpoint is the mean increase from baseline in points seen on the HVF 36-point ptosis protocol test at various timepoints according to a hierarchical analysis.
Analysis of exploratory endpoints will provide characterization of the efficacy and duration of effect of RVL-1201 with a variety of efficacy measures, as well as the potential additional effect of BID over QD dosing and safety profile of BID administration of RVL-1201. Exploratory endpoints will be analyzed by each regimen against placebo and between regimens and will include:
- The change from baseline in HVF, MRD, PFD, VA, and CS.
- The change from baseline in BP/HR
|Contact: Drey Colemanemail@example.com|
|United States, California|
|Sall Research Medical Center||Recruiting|
|Artesia, California, United States, 90701|
|Contact: Ilanie Shiell 562-804-1974 firstname.lastname@example.org|
|Principal Investigator: Kenneth Sall, MD|
|United States, Georgia|
|Clayton Eye Center||Recruiting|
|Morrow, Georgia, United States, 30260|
|Contact: Ann Susan Nyawira 770-968-8888 email@example.com|
|Principal Investigator: Harvey Dubiner, MD|
|United States, Texas|
|Texan Eye/Keystone Research||Recruiting|
|Austin, Texas, United States, 78731|
|Contact: Robert Stapper 512-451-4400 firstname.lastname@example.org|
|Principal Investigator: Thomas Walters, MD|
|The Cataract and Glaucoma Center||Recruiting|
|El Paso, Texas, United States, 79902|
|Contact: Terry Cintron 915-545-2333 email@example.com|
|Contact: Monica Gomez 915-545-2333 firstname.lastname@example.org|
|Principal Investigator: Louis Alpern|
|Medical Center Ophthalmology Associates||Recruiting|
|San Antonio, Texas, United States, 78240|
|Contact: Brian Matthews 210-364-8904 email@example.com|
|Principal Investigator: Richard Evans, MD|