A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Pati… (NCT05335122) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)
United States83 participantsStarted 2022-03-16
Plain-language summary
To assess efficacy, and safety of a single sustained release dose of the OTX-TIC drug product (2 travoprost dose strengths) in subjects with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT)
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:
* Are 18 years of age or older at the time of screening
* Provide written informed consent and are able to comply with all study requirements
* Are willing to withhold glaucoma medications according to the study requirements, and in the opinion of the investigator can do so without significant risk
* Have a negative pregnancy test result for women of childbearing potential at Baseline
* Have a documented diagnosis of OHT, or OAG in the study eye
Exclusion Criteria:
* Have an uncontrolled systemic disease or a debilitating disease (e.g., cardiovascular, hypertension, uncontrolled diabetes)
* Are currently pregnant or breast-feeding or of childbearing potential without the use of adequate contraceptive methods during the length of the study
* Non-responsive to topical prostaglandins, prostamides or prostaglandin analogs
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
Efficacy Outcome: IOP changes from Baseline
Timeframe: Diurnal IOP [Time Frame: diurnal IOP at the 2 Week Visit] Diurnal IOP [Time Frame: diurnal IOP at the 6 Week Visit] Diurnal IOP [Time Frame: diurnal IOP at the 12 Week Visit]