Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis (NCT02436759) | Clinical Trial Compass
CompletedPhase 3
Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis
United States140 participantsStarted 2015-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female subjects 18 years of age and older.
✓. Presence of all of the following at Screening :
✓. Presence of all of the following at Baseline:
✓. Female subjects must be 1 year postmenopausal, surgically sterilized, or women of childbearing potential with a negative urine pregnancy test at Visit 1. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include the use of at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.
✓. Able to self-administer study medication or to have the study medication administered by a caregiver throughout the study period.
✓. Subjects must be able to understand and sign an IRB approved informed consent form prior to participation in any study-related procedures.
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group
Timeframe: Mean change from Baseline (Day 1, Hour 0) compared with Day 1, Hour 6 and Day 14, Hour 2
✕. Mechanical ptosis, including ptosis due to orbital or lid tumor, cicatricial processes affecting the movements of the upper lid, and enophthalmos.