A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery

Formosa Pharmaceuticals, Inc.165 enrolled

Overview

This is a Phase 2a, 2-part study (designated Parts A and B) that will evaluate APP13007 dose strength and dosing frequency in a randomized double-masked fashion for comparison to the respective matching vehicle placebo. Part A will be conducted first to evaluate 0.05% APP13007 and matching vehicle placebo in an approximate 1:1 ratio in approximately 42 subjects who experience postoperative inflammation on the first day following routine, uncomplicated, cataract surgery and who meet all eligibility criteria. Based on the results of Part A, Part B of the study may be open for enrollment to evaluate 0.05% and/or 0.1% APP13007 at various dosing frequency in approximately 84 subjects, also in an approximate 1:1 ratio, active vs. placebo. In each Part, subjects will return periodically for study assessments during the treatment period and then for a follow-up visit approximately 1 week after stopping the study drug.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

165

Conditions

Ocular Inflammation and Pain After Cataract Surgery

Interventions

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye. * In Investigator's opinion, have Early Treatment Diabetic Retinopathy Study estimated potential of 0.7 (20/100) or better in study eye. * Have \> 10 and ≤ 30 cells in anterior chamber. * Have an intraocular pressure ≤ 30 mmHg. Exclusion Criteria: * Have an anterior chamber cell count \> 0 or any evidence of intraocular inflammation. * Have a score \> 0 on Ocular Pain Assessment in either eye.

Locations (9)

Cornea and Cataract Consultants of Arizona

Phoenix, Arizona, United States

United Medical Research Institute

Inglewood, California, United States

Martel Eye Medical Group

Rancho Cordova, California, United States

Levenson Eye Associates

Jacksonville, Florida, United States

Bowden Eye and Associates

Jacksonville, Florida, United States

Ophthalmology Associates

St Louis, Missouri, United States

Eye Care Specialists

Kingston, Pennsylvania, United States

Keystone Research Ltd.

Austin, Texas, United States

Cataract & Glaucoma Center

El Paso, Texas, United States

Outcomes

Primary Outcomes

Number of Treatment Emergent Adverse Events

Number of treatment emergent adverse events and number of participants.

Time frame: From First dose to Post-operative Day 28 (Part A) or Day 22 (Part B)

Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye

Intraocular pressure is measured in mm Hg at each study visit with a Goldmann applanation tonometer. The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit.

Time frame: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)

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

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: Baseline and Post-operative Day 15

Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye

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 number of incorrect letters.

Time frame: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)

Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye

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

Time frame: Baseline and Post-operative Day 15

Secondary Outcomes

Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye 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: Post-operative Day 15

Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication

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

Time frame: Post-operative Day 15

Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye

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). The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit.

Time frame: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)

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

Subjects who do not respond to study treatment after randomization (anterior chamber cell count \> 30 cells or an increase in anterior chamber cell count by \> 15 cells from pre-dose baseline or ≥ 2 grade of increase in anterior chamber flare from pre-dose baseline) 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 Post-operative Day 22 (Part A) or Day 15 (Part B)