Mapracorat Ophthalmic Suspension for the Treatment of Ocular Inflammation Following Cataract Surgery (NCT01230125) | Clinical Trial Compass
CompletedPhase 3
Mapracorat Ophthalmic Suspension for the Treatment of Ocular Inflammation Following Cataract Surgery
United States311 participantsStarted 2010-11
Plain-language summary
The objective of this clinical study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following 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:
* Participants who are candidates for routine, uncomplicated cataract surgery
* Participants who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
* Participants must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.
Exclusion Criteria:
* Participants who are expected to require concurrent ocular therapy (either eye) with nonsteroidal anti-inflammatory drugs (NSAIDs), mast cell stabilizers, antihistamines, or decongestants.
* Participants who are expected to require treatment with any systemic or ocular (either eye) corticosteroids or glucocorticoids.
* Participants who are expected to require concurrent ocular therapy with immunosuppressants (eg, Restasis).
* Participants who have known hypersensitivity or contraindication to the study drug(s) or their components.
* Participants participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
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
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.