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

NCT03496467 | Completed Phase 2 Results FDA Drug FDA Device

• 1 other identifier: NPIF-2018-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 3

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.

Conditions

Pain; Inflammation

Keywords

Treatment of pain and inflammation after Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Assessment of Anterior Chamber Cells

  day 14

• Assessment of Flare

  day 14

Study Arms (2)

Nepafenac PPDS

ACTIVE COMPARATOR

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

Placebo PPDS

PLACEBO COMPARATOR

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

Interventions

Nepafenac PPDS COMBINATION_PRODUCT

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.

Nepafenac PPDS

Placebo PPDS COMBINATION_PRODUCT

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.

Placebo PPDS

Eligibility Criteria

• Age: 22 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mati Therapeutics Inc.: lead

Study Sites (3)

Cincinnati Eye Institute-Edgewood

Edgewood, Kentucky, 41017, United States

Location

Ophthalmic Consultants of Long Island

Garden City, New York, 11530, United States

Location

Kerry Solomon, MD

Mt. Pleasant, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

Pain; Inflammation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Results Point of Contact

• Title: Deepank Utkhede
• Organization: Mati Therapeutics

dutkhede@matitherapeutics.com

6046379717

Study Officials

• Deepank Utkhede

  Mati Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 12, 2018
• Study Start: March 5, 2018
• Primary Completion: December 17, 2018
• Study Completion: December 17, 2018
• Last Updated: October 12, 2021
• Results First Posted: October 12, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)