A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%

Completed · Phase 4

Conditions studied: Cataract

In brief

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.

Key facts

Study ID

NCT04273282

Run by

Research Insight LLC

People needed

31

Starts

2019-12-16

Expected to finish

2020-11-24

Last updated by the study team

2020-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 disease or illness that would increase risk or confound study results, e.g. autoimmune disease, etc.
• Subject with an uncontrolled systemic disease.
• Subject with poorly-controlled diabetes.
• Subject currently participating or has participated in another clinical trial within 30 days prior to enrollment.

Where it is running

• Harvard Eye Associates — Laguna Hills, California, United States
• Ophthalmic Consultants of Long Island — Garden City, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.