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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03496467
Recruitment Status : Completed
First Posted : April 12, 2018
Results First Posted : October 12, 2021
Last Update Posted : October 12, 2021
Sponsor:
Information provided by (Responsible Party):
Mati Therapeutics Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pain Inflammation Combination Product: Nepafenac PPDS Combination Product: Placebo PPDS Phase 2

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
Drug Information available for: Nepafenac

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Mati Therapeutics Inc.
Investigators
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Study Director: Deepank Utkhede Mati Therapeutics
  Study Documents (Full-Text)

Documents provided by Mati Therapeutics Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] August 27, 2018

More Information
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Responsible Party: Mati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03496467    
Other Study ID Numbers: NPIF-2018-01
First Posted: April 12, 2018    Key Record Dates
Results First Posted: October 12, 2021
Last Update Posted: October 12, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Mati Therapeutics Inc.:
Treatment of pain and inflammation after Cataract Surgery
Additional relevant MeSH terms:
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Cataract
Inflammation
Pathologic Processes
Lens Diseases
Eye Diseases
Nepafenac
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents