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 range18 Years
SexALL
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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…
What they're measuring
1
Patient preference for medication protocol in 30 randomized subjects