Phase 2
Completed N=56
Safety/Efficacy of Nepafenac Punctal Plug Delivery System Compared to Placebo to Control Ocular Pain/Inflammation After Cataract
Source: ClinicalTrials.gov NCT03496467 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Assessment of Pain — 30; 13; 2; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Pain |
30; 13; 2; 0; 2; 1 | — |
| SECONDARY Assessment of Anterior Chamber Cells |
22; 7; 7; 3; 5; 4 | — |
| SECONDARY Assessment of Flare |
29; 10; 3; 1; 2; 3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03496467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.