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


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.

Study Start Date

March, 05 2018

Estimated Completion Date

September 2018


  • Combination Product: Nepafenac PPDS
  • Combination Product: Placebo PPDS

Study ID

Mati Therapeutics Inc. -- NPIF-2018-01



Trial ID


Study Type


Trial Phase

Phase 2

Enrollment Quota



Mati Therapeutics Inc.

Inclusion Criteria

    1. A male or female subject in good general health, ? 22 years of age at the time of the screening visit 2. A subject with a cataract for which routine phacoemulsification extraction and implantation of an intraocular lens has been planned 3. A subject has a lower puncta that can be dilated to 1.0 mm in their scheduled surgical eye

Exclusion Criteria

    1. 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 2. A subject with structural lid abnormalities (e.g., ectropion, entropion) in their schedule surgical eye 3. A subject with a puncta >0.9 mm prior to dilation in their scheduled surgical eye 4. A subject with any signs of intraocular inflammation (cells/flare) in either eye at the screening visit 5. 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 6. A subject with a history of chronic/recurrent inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis) in either eye




22 Years to 99 Years

Accepts Healthy Volunteers


Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
Ophthalmic Consultants of Long Island - Garden City, New York 175.9 miles Eric Donnenfeld MD 516-500-4201 None
Cincinnati Eye InstituteEdgewood - Edgewood, Kentucky 742.9 miles Edward Holland MD 859-331-9000 None provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.