Safety/Efficacy of Nepafenac Punctal Plug Delivery System Compared to Placebo to Control Ocular Pain/Inflammation After Cataract

Phase 2

Completed

Interventions: Combination Product: Nepafenac PPDS
Combination Product: Placebo PPDS

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

A male or female subject in good general health, ≥ 22 years of age at the time of the screening visit
A subject with a cataract for which routine phacoemulsification extraction and implantation of an intraocular lens has been planned
A subject has a lower puncta that can be dilated to 1.0 mm in their scheduled surgical eye

Exclusion Criteria

A subject with a history of complications, adverse events, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in either eye
A subject with structural lid abnormalities (e.g., ectropion, entropion) in their schedule surgical eye
A subject with a puncta >0.9 mm prior to dilation in their scheduled surgical eye
A subject with any signs of intraocular inflammation (cells/flare) in either eye at the screening visit
A subject with a known sensitivity to nepafenac or any inactive ingredient of the punctum plug, silicone, fluorescein, topical anesthetic, or any other products required for study procedures or cataract surgery
A subject with a history of chronic/recurrent inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis) in either eye

Arm && Interventions

Group	Intervention	Description
Nepafenac PPDS	Nepafenac PPDS	N-PPDS (Nepafenac Punctal Plug Deliver System) is an L-shaped, silicone punctal plug with a drug eluting core that contains nepafenac (active)
Placebo PPDS	Placebo PPDS	p-PPDS (placebo Punctal Plug Delivery System) is an L-shaped, silicone punctal plug with a drug insert that contains no active ingredient (placebo).

Primary Outcome Measures

Name	Time	Method
Assessment of Pain	day 14	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of Flare	day 14	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
Assessment of Anterior Chamber Cells	day 14	Anterior chamber cells are assessed using a scale of 0 - 4 with 0 representing no cells seen and 4 representing \>30 cells seen.

Locations (3): Kerry Solomon, MD
🇺🇸
Mount Pleasant, South Carolina, United States
Cincinnati Eye Institute-Edgewood
🇺🇸
Edgewood, Kentucky, United States
Ophthalmic Consultants of Long Island
🇺🇸
Garden City, New York, United States