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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03496467
• Other study ID #: NPIF-2018-01
• Status: Completed
• Phase: Phase 2
• Start date: March 5, 2018
• Est. completion date: December 17, 2018

Study information

• Verified date: September 2021
• Source: Mati Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 17, 2018
• Est. primary completion date: December 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Inflammation
• Pain

Intervention

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 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.

Locations

Country	Name	City	State
United States	Cincinnati Eye Institute-Edgewood	Edgewood	Kentucky
United States	Ophthalmic Consultants of Long Island	Garden City	New York
United States	Kerry Solomon, MD	Mount Pleasant	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Mati Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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