July 2019
Volume 60, Issue 9
Free
ARVO Annual Meeting Abstract  |   July 2019
A Clinical Study Evaluating the Safety and Efficacy of a Punctal Plug Delivery System of Nepafenac (N-PPDS) in Controlling Post-Operative Ocular Pain and Inflammation in Subjects Undergoing Routine Unilateral Cataract Surgery
Author Affiliations & Notes
  • Deepank Utkhede
    Mati Therapeutics Inc., Burnaby, British Columbia, Canada
  • Robert Williams
    Mati Therapeutics Inc., Burnaby, British Columbia, Canada
  • Footnotes
    Commercial Relationships   Deepank Utkhede, Mati Therapeutics Inc. (E); Robert Williams, Mati Therapeutics Inc. (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 3371. doi:
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    • Get Citation

      Deepank Utkhede, Robert Williams; A Clinical Study Evaluating the Safety and Efficacy of a Punctal Plug Delivery System of Nepafenac (N-PPDS) in Controlling Post-Operative Ocular Pain and Inflammation in Subjects Undergoing Routine Unilateral Cataract Surgery. Invest. Ophthalmol. Vis. Sci. 2019;60(9):3371.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : More than 3.5 million cataract surgeries are performed annually. Post-operative ocular pain and inflammation associated with this procedure is currently treated with topical medication however, studies have shown that upwards of 92.6% of patients incorrectly administer topical medications which can lead to complications and negative clinical outcomes. This clinical study is to evaluate the safety and efficacy of N-PPDS, a ocular sustained release delivery system by Mati Therapeutics Inc., in controlling post-operative ocular pain and inflammation. Subjects did not administer topical medications.

Methods : This is a Phase 2, multi-center, randomized, parallel-arm, double-masked, placebo-controlled study. One (1) to 2 days prior to cataract surgery, each study subject was randomized (2:1) to one of two treatment groups: 1) Group A - subjects had a N-PPDS (Active) inserted in the lower punctum of their scheduled surgical eye or 2) Group B - subjects had a P-PPDS (Placebo) inserted in the lower punctum of their scheduled surgical eye. At days 1, 3, 7 and 14 post operation, the surgical eye was assessed for ocular pain, anterior chamber cells and flare and adverse events. The target enrolment was 75 subjects with the current analysis completed after 44 subjects were enrolled.

Results : 45% of patients in the active arm experienced zero pain at any time during the trial as compared to 0% of patients in the placebo arm. At day 3 post surgery, ocular pain was 0.7 for N-PPDS vs. 1.7 for placebo, anterior chamber cells were 1.1 for N-PPDS vs 1.8 for placebo and anterior chamber flare was 0.2 for N-PPDS vs 0.7 for placebo. Ocular pain had fully resolved at day 14 with N-PPDS and placebo exhibiting 0 pain values. The results demonstrate that N-PPDS successfully and rapidly managed post-operative pain and inflammation associated with cataract surgery. There were no unexpected adverse events observed.

Conclusions : The interim results from this clinical study examining the Nepafenac Punctal Plug Delivery System to control post-operative pain and inflammation in subjects undergoing cataract surgery demonstrated that sustained release Nepafenac was safe and effective. N-PPDS rapidly controlled pain and inflammation which will result in improved clinical outcomes and subject comfort.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

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