Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study

Formosa Pharmaceuticals, Inc.370 enrolled

Overview

This Phase 3 study will evaluate APP13007 in comparison to the matching vehicle placebo in a randomized, parallel-group, double-masked fashion. The subjects will have undergone routine cataract surgery on Day 0 of the study and will be assessed the next day (Post-operative Day; POD1) after uncomplicated surgery for eligibility for randomization to study treatment. The study comprises the Main Study and the Endothelial Cell Sub-study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

370

Conditions

Ocular Inflammation and Pain After Cataract Surgery

Interventions

APP13007, 0.05%

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients 18 years of age or older expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye. * Have a pin-hole corrected visual acuity without other correction of ≤ 1.3 logarithm of the minimum angle of resolution (logMAR) in the study eye to be operated and contralateral eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Visit 1. * Willing and able to comply with study requirements and visit schedule. * Provide signed and dated informed consent. Exclusion Criteria: * Have a known sensitivity or allergy to clobetasol propionate, corticosteroids, or any of the study medication's components including benzalkonium chloride and soybean lecithin or any routine medication required during cataract surgery or for the conduct of study procedures * Have an ACC count \> 0 or any evidence of intraocular inflammation (e.g., flare) in either eye at the Screening visit * Have a Grade \> 0 on the Ocular Pain Assessment in either eye at the Screening visit Note: Other inclusion/exclusion criteria apply.

Locations (31)

Arizona Eye Center

Chandler, Arizona, United States

Carrot Eye Center

Mesa, Arizona, United States

Cornea and Cataract Consultants of Arizona

Phoenix, Arizona, United States

Orange County Ophthalmology Medical Group

Garden Grove, California, United States

Premiere Practice Management, LLC

Los Angeles, California, United States

Outcomes

Primary Outcomes

Participants With ACC Count = 0 in the Operated Study Eye at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication

The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area.

Time frame: Postoperative Day 8 and Postoperative Day 15

Participants With Ocular Pain Grade = 0 in the Operated Study Eye at All Visits From Postoperative Day 4 Through Postoperative Day 15 Without Rescue Medication

Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 1 = minimal; 2 = mild; 3 = moderate; 4 = severe pain).

Time frame: Postoperative Day 4, Postoperative Day 8 and Postoperative Day 15

Participants With Treatment-emergent Adverse Events (AEs)

Number of participants with ocular and systemic treatment-emergent AEs.

Time frame: From First dose to Postoperative Day 22 (End of Main Study)

Secondary Outcomes

Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication

The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area.ACC Grade 0 = 0 cells, ACC grade 1 = 1-5 cells, ACC grade 2 = 6-15 cells, ACC grade 3 = 16-30 cells, ACC grade 4 = \>30 cells.

Time frame: Postoperative Day 8

Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication

The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area. ACC Grade 0 = 0 cells, ACC grade 1 = 1-5 cells, ACC grade 2 = 6-15 cells, ACC grade 3 = 16-30 cells, ACC grade 4 = \>30 cells.

Time frame: Postoperative Day 15

Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD4 Without Rescue Medication

Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).

Time frame: Postoperative Day 4

Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication

Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).

Time frame: Postoperative Day 8

Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication

Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).

Time frame: Postoperative Day 15

Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD4 Without Rescue Medication

The degree of turbidity (flare) in the anterior chamber of the eye is measured using slit-lamp biomicroscopy and quantified on a five-point (0-4) anterior chamber flare grade scale (0 = none; 4 = Intense).

Time frame: Postoperative Day 4

Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD8 Without Rescue Medication

Time frame: Postoperative Day 8

Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD15 Without Rescue Medication

Time frame: Postoperative Day 15

Anterior Chamber Cell Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15

The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy and the results are reported as number of cells in a 1mm x 1mm area using a 5 point grading scale. ACC Grade 0 = 0 cells, ACC grade 1 = 1-5 cells, ACC grade 2 = 6-15 cells, ACC grade 3 = 16-30 cells, ACC grade 4 = \>30 cells

Time frame: Baseline and Postoperative Day 15

Ocular Pain Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15

Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 1 = minimal; 2 = mild; 3 = moderate; 4 = severe pain).

Time frame: Baseline and Postoperative Day 15

Anterior Chamber Flare (ACF) in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15

Time frame: Baseline and Postoperative Day 15

Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD4

The visual acuity in each eye is corrected using the pinhole method and the acuity is quantified on a logMAR (minimal angle of resolution) scale using the 'Early Treatment Diabetic Retinopathy Study' \[ETDRS\] charts for right and left eyes. A logMAR Score is calculated using the letter row on the chart and the number of incorrect letters read by the participant.

Time frame: Baseline and Postoperative Day 4

Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD8

Time frame: Baseline and Postoperative Day 8

Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD15

Time frame: Baseline and Postoperative Day 15

Participants Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment

Participants who do not respond to study treatment after randomization are started on anti-inflammatory medication (referred to as 'Rescue' medication). The number of subjects starting 'Rescue' medication is recorded at each study visit

Time frame: First dose to Postoperative Day 15