Safety/Efficacy of Nepafenac Punctal Plug Delivery System Compared to Placebo to Control Ocular Pain/Inflammation After Cataract
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|ClinicalTrials.gov Identifier: NCT03496467|
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : October 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain Inflammation||Combination Product: Nepafenac PPDS Combination Product: Placebo PPDS||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Clinical Study Evaluating Safety and Efficacy of a Nepafenac Punctal Plug Delivery System (N-PPDS) Compared With Placebo Punctal Plug Delivery System (p-PPDS) in Controlling Post-Operative Ocular Pain and Inflammation After Routine Unilateral Cataract Surgery|
|Actual Study Start Date :||March 5, 2018|
|Actual Primary Completion Date :||December 17, 2018|
|Actual Study Completion Date :||December 17, 2018|
Active Comparator: 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)
Combination Product: Nepafenac PPDS
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.
Placebo Comparator: 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).
Combination Product: Placebo PPDS
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.
- Assessment of pain [ Time Frame: 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.
- Assessment of anterior chamber cells [ Time Frame: 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.
- Assessment of flare [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496467
|United States, Kentucky|
|Cincinnati Eye Institute-Edgewood|
|Edgewood, Kentucky, United States, 41017|
|United States, New York|
|Ophthalmic Consultants of Long Island|
|Garden City, New York, United States, 11530|
|United States, South Carolina|
|Kerry Solomon, MD|
|Mount Pleasant, South Carolina, United States, 29464|
|Study Director:||Deepank Utkhede||Mati Therapeutics|