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

Primary Purpose

Pain, Inflammation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nepafenac PPDS
Placebo PPDS
Sponsored by
Mati Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Treatment of pain and inflammation after Cataract Surgery

Eligibility Criteria

22 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cincinnati Eye Institute-Edgewood
  • Ophthalmic Consultants of Long Island
  • Kerry Solomon, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nepafenac PPDS

Placebo PPDS

Arm Description

N-PPDS (Nepafenac Punctal Plug Deliver System) is an L-shaped, silicone punctal plug with a drug eluting core that contains nepafenac (active)

p-PPDS (placebo Punctal Plug Delivery System) is an L-shaped, silicone punctal plug with a drug insert that contains no active ingredient (placebo).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
March 21, 2018
Last Updated
September 16, 2021
Sponsor
Mati Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03496467
Brief Title
Safety/Efficacy of Nepafenac Punctal Plug Delivery System Compared to Placebo to Control Ocular Pain/Inflammation After Cataract
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
December 17, 2018 (Actual)
Study Completion Date
December 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mati Therapeutics Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Inflammation
Keywords
Treatment of pain and inflammation after Cataract Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nepafenac PPDS
Arm Type
Active Comparator
Arm Description
N-PPDS (Nepafenac Punctal Plug Deliver System) is an L-shaped, silicone punctal plug with a drug eluting core that contains nepafenac (active)
Arm Title
Placebo PPDS
Arm Type
Placebo Comparator
Arm Description
p-PPDS (placebo Punctal Plug Delivery System) is an L-shaped, silicone punctal plug with a drug insert that contains no active ingredient (placebo).
Intervention Type
Combination Product
Intervention Name(s)
Nepafenac PPDS
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Placebo PPDS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of Pain
Description
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.
Time Frame
day 14
Secondary Outcome Measure Information:
Title
Assessment of Anterior Chamber Cells
Description
Anterior chamber cells are assessed using a scale of 0 - 4 with 0 representing no cells seen and 4 representing >30 cells seen.
Time Frame
day 14
Title
Assessment of Flare
Description
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
Time Frame
day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepank Utkhede
Organizational Affiliation
Mati Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Cincinnati Eye Institute-Edgewood
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Kerry Solomon, MD
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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