A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1% (NCT04273282) | Clinical Trial Compass
CompletedPhase 4
A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%
United States31 participantsStarted 2019-12-16
Plain-language summary
This is a post-approval, open-label, randomized, self-controlled prospective clinical study to evaluate the safety and ocular efficacy of Dexycu in controlling postoperative ocular pain and inflammation associated with 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:
* A male or female in good general health, greater than 18 years of age at time of screening.
* Must be able to comprehend and willing to give informed consent.
* Woman of child-bearing potential must not be pregnant or lactating.
* Subject has availability, willingness, and sufficient cognitive awareness to comply with exam procedures and able to return for all scheduled study visits.
* Subject with cataract for which routine phacoemulsification extraction and implantation of an intraocular lens has been planned.
* Subject with an OCT of the macula in both eyes that demonstrates no significant pathology.
Exclusion Criteria:
* Subject with any signs of intraocular inflammation in either eye at screening.
* Subject with a known sensitivity to any of the study medications.
* Subject with only one eye with potentially good vision.
* Subject that has undergone prior intraocular surgery in the scheduled surgical eye within the last 6 months or laser surgery within three months prior to screening.
* Subject with pupil abnormalities.
* Subject with corneal abnormalities.
* Subject with a history of chronic/recurrent inflammatory eye disease in either eye.
* Subject with uncontrolled glaucoma.
* Subject expected to undergo surgical intervention and/or ocular laser treatment prior to or during the study period.
* Subject who requires use of systemic or ocular medications that may affect vision, ocular inflammation, or pain.
* Subject with an acute or chronic dis…
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
Patient preference for medication protocol in 30 randomized subjects