Safety/Efficacy of Nepafenac Punctal Plug Delivery System Compared to Placebo to Control Ocular Pain/Inflammation After Cataract
Condition: Pain; Inflammation
MeSH terms: Cataract; Inflammation
Intervention: Nepafenac PPDS; Placebo PPDS
Intervention description: 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.
Intervention MeSH terms: Nepafenac
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 22 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Treatment of pain and inflammation after Cataract Surgery

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.
    

Eligibility criteria:

        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