Safety and Efficacy Study of RVL-1201 in Acquired Blepharoptosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01848041|
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : January 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Blepharoptosis||Drug: RVL-1201 Drug: RVL-1201 Vehicle Placebo||Phase 1 Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||February 2014|
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
Drug: RVL-1201 Vehicle Placebo
RVL-1201 Vehicle Placebo
- Humphrey Visual Field [ Time Frame: 14 days ]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 ]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 ]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 ]The Pelli-Robson contrast sensitivity chart will be used at a distance of 1 meter.
- Safety [ Time Frame: 14 days ]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.
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): NCT01848041
|United States, Georgia|
|Morrow, Georgia, United States|