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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Pain, Inflammation

Intervention / Treatment
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* Combination Product: Nepafenac PPDS
* Combination Product: Placebo PPDS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nepafenac PPDS<br>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<br>* 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.<br>|
| Placebo Comparator: Placebo PPDS<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Pain | 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. | day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Anterior Chamber Cells | Anterior chamber cells are assessed using a scale of 0 - 4 with 0 representing no cells seen and 4 representing >30 cells seen. | day 14 | 
| Assessment of Flare | 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 | day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment of pain and inflammation after Cataract Surgery