Clinical trial NCT03496467: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Inflammation
Keywords: Treatment of pain and inflammation after Cataract Surgery
Lead sponsor: Mati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-12
Enrollment: 56
Sex: ALL
Minimum age (years): 22
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Assessment of Pain
timeFrame: day 14
Secondary outcomes:
measure: Assessment of Anterior Chamber Cells
timeFrame: day 14
measure: Assessment of Flare
timeFrame: day 14
Other outcomes:
Locations:
city: Edgewood
country: United States
facility: Cincinnati Eye Institute-Edgewood
state: Kentucky
city: Garden City
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Mount Pleasant
country: United States
facility: Kerry Solomon, MD
state: South Carolina
Study officials:
affiliation: Mati Therapeutics
name: Deepank Utkhede
role: STUDY_DIRECTOR
References: