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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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