RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular … (NCT02065375) | Clinical Trial Compass
CompletedPhase 2
RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
United States109 participantsStarted 2014-02-28
Plain-language summary
This study assesses the efficacy and safety of two concentrations of RTA 408 Ophthalmic Suspension in the treatment of patients who have inflammation and pain following ocular 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
. Be greater than or equal to 18 years of age of either sex or any race;
. Have undergone unilateral cataract extraction via phacoemulsification on the day prior to study enrollment/randomization;
. Have a grade of ≥2 in anterior chamber cell score on day after surgery (Day 1);
. Have a potential post-operative pin-hole visual acuity (VA) of greater than 1.0 logarithm of the minimum angle of resolution (logMAR) in the operative eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart;
Exclusion criteria
. Have any intraocular inflammation present in the study eye during the screening slit lamp examination;
. Have a score greater than "0" on the Ocular Pain Assessment at Screening in the study eye;
. Have an immunosuppressive disease or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface;
. Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing;
. Have an intraocular pressure (IOP) ≤ 5 mmHg in either eye;
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
Absence of Anterior Chamber Cells at Day 15 (Visit 5)
Timeframe: 15 days after the participant receives the first dose
2
Absence of Ocular Pain at Day 4 (Visit 3)
Timeframe: 4 days after the participant receives the first dose
. Require the use of a contact lens or a collagen shield within 72 hours of investigational drug treatment or during the study period in the study eye; be unwilling to discontinue use of contact lenses during study period in the study eye;
. Require use of non-diagnostic topical ophthalmic solutions (other than perioperative mydriatics, anesthetics and antiseptics, prophylactic antibiotics, lid scrubs for mild blepharitis, or artificial tears for the management of dry eye) in the study eye for the duration of the study;