Status:
COMPLETED
A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%
Lead Sponsor:
Research Insight LLC
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 inflammati...
Detailed Description
On initial consultation, each study subject will be randomized by a table in the possession of investigators to receive one of two treatment groups, either experimental or control in the first eye. Th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2020
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04273282
Start Date
December 16 2019
End Date
November 24 2020
Last Update
December 11 2020
Active Locations (2)
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1
Harvard Eye Associates
Laguna Hills, California, United States, 92653
2
Ophthalmic Consultants of Long Island
Garden City, New York, United States, 11530