A Study of TRS01 in Participants With Post-surgical Ocular Inflammation (NCT04222725) | Clinical Trial Compass
CompletedPhase 1/2
A Study of TRS01 in Participants With Post-surgical Ocular Inflammation
United States37 participantsStarted 2020-02-01
Plain-language summary
The objective of this study is to evaluate the safety and preliminary efficacy of TRS01 eye drops as compared to placebo on participants with ocular inflammation after cataract surgery.
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:
Pre-operatively, individuals of either gender or any race will be eligible for study participation if they are:
* 18 years of age or older.
* Able to provide informed consent, follow instructions and complete all required study visits for the duration of the study.
* Scheduled for routine cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens (IOL) implantation, and not combined with any other surgery.
* Have vision ≥ 20/200 in the non-study eye.
* Able to self-administer eye drops (tested during screening by self-administration of "artificial tears"), or have a care provider that can administer the drops.
* Have no known sensitivity /allergy to the TRS01 or formulation excipients.
* Using adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol
* Randomization inclusion criteria as specified per protocol.
Exclusion Criteria:
* Scheduled to undergo cataract surgery in the non-study eye for the duration of the study.
* Receiving specific medication/interventions as specified per protocol
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
Assessment of Both Systemic and Ocular Adverse Events