This is a Phase 2, multi-center, randomized, parallel-arm, double-masked, placebo-controlled study. One (1) to 2 days prior to their scheduled cataract surgery, each study subject will be randomized (2:1) in to one of two treatment groups: N-PPDS or p-PPDS, which are inserted in the lower punctum of the subject's scheduled surgical eye. All plugs will remain in the study subject's lower punctum for a period of 2 weeks following cataract surgery.
This is a Phase 2, multi-center, randomized, parallel-arm, double-masked, placebo-controlled study. One (1) to 2 days prior to their scheduled cataract surgery, each study subject will be randomized (2:1) in to one of two treatment groups: Group A: A total of 50 study subjects (50 eyes) will have an N-PPDS inserted in the lower punctum of their scheduled surgical eye. Group B: A total of 25 study subjects (25 eyes) will have a p-PPDS inserted in the lower punctum of their scheduled surgical eye. All plugs will remain in the study subject's lower punctum for a period of 2 weeks following cataract surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that contains nepafenac, a nonsteroidal anti-inflammatory drug.
A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that does not contain nepafenac.
Cincinnati Eye Institute-Edgewood
Edgewood, Kentucky, United States
Ophthalmic Consultants of Long Island
Garden City, New York, United States
Kerry Solomon, MD
Mt. Pleasant, South Carolina, United States
Assessment of Pain
Assessment of pain in subjects as measured by a scale of 0 - 5. Post-op pain scale: 0 represents absence of pain and 5 represents a definite, continuous unbearable ocular or periocular pain.
Time frame: day 14
Assessment of Anterior Chamber Cells
Anterior chamber cells are assessed using a scale of 0 - 4 with 0 representing no cells seen and 4 representing \>30 cells seen.
Time frame: day 14
Assessment of Flare
Anterior chamber flare is assessed using a scale of 0 - 4 with 0 representing no Tyndall effect and 4 representing Tyndall effect in anterior chamber is very intense
Time frame: day 14
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