Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery

A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of APP13007 for the Treatment of Inflammation and Pain After Cataract Surgery

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 1; POD1) after uncomplicated surgery for eligibility for randomization to study treatment.

Study Overview

• Status: Completed
• Conditions: Ocular Inflammation and Pain
• Intervention / Treatment: Drug: APP13007, 0.05%; Drug: Matching Vehicle Placebo for APP13007, 0.05%

• Study Type: Interventional
• Enrollment (Actual): 378
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00921
    • Centro Oftalmologico Metropolitano
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Schwartz Laser Eye Center
  • California
    • Glendale, California, United States, 91204
      • Global Research Management
    • Hemet, California, United States, 92545
      • Inland Eye Specialists
    • Long Beach, California, United States, 90805
      • SoCal Eye Physicians and Associates
    • Mission Hills, California, United States, 91345
      • North Valley Eye Medical Group, Inc.
    • Murrieta, California, United States, 92562
      • LoBue Laser and Eye Medical Center, Inc.
    • Oceanside, California, United States, 92056
      • Pendleton Eye Center
    • Rancho Cordova, California, United States, 95670
      • Martel Eye Medical Group
    • Redding, California, United States, 96001
      • Shasta Eye Medical Group, Inc.
  • Colorado
    • Grand Junction, Colorado, United States, 81501
      • ICON Eye Care
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Levenson Eye Associates
    • Ormond Beach, Florida, United States, 32174
      • International Eye Associates, PA
    • Sebring, Florida, United States, 33870
      • Newsom Eye and Laser Center
  • Georgia
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates, LLC
  • Illinois
    • Columbus, Illinois, United States, 60046
      • Jacksoneye SC
  • Indiana
    • Carmel, Indiana, United States, 46290
      • Midwest Cornea Associates, LLC
  • Kentucky
    • Louisville, Kentucky, United States, 40220
      • Senior Health Services
  • Missouri
    • Kansas City, Missouri, United States, 64133
      • Silverstein Eye Centers, PC
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Consultants, Ltd.
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care, Ltd.
  • Nevada
    • Henderson, Nevada, United States, 89052
      • NV Eye Surgery
    • Las Vegas, Nevada, United States, 89145
      • Center For Sight
  • New York
    • New York, New York, United States, 10013
      • Raymond Fong, MD, PC
  • North Carolina
    • Southern Pines, North Carolina, United States, 28387
      • Carolina Eye Associates
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Eye Physicians, LLC
  • Pennsylvania
    • Wilkes-Barre, Pennsylvania, United States, 18702
      • Bucci Laser Vision Institute
  • Texas
    • Austin, Texas, United States, 78731
      • Keystone Research Ltd.
    • Austin, Texas, United States, 78750
      • Retina Research Center, PLLC
    • Houston, Texas, United States, 77008
      • Houston Eye Associates
    • Houston, Texas, United States, 77034
      • Advanced Laser Vision and Surgical Institute
    • Lakeway, Texas, United States, 78738
      • Lake Travis Eye and Laser Center
    • San Antonio, Texas, United States, 78229
      • R and R Eye Research, LLC
    • San Antonio, Texas, United States, 78238
      • San Antonio Eye Center
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Stacy R. Smith, MD, PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: APP13007 0.05% BID; 1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye	Drug: APP13007, 0.05%; APP13007 eye drop, 0.05%
Placebo Comparator: Matching Vehicle Placebo; 1 drop matching vehicle place twice daily for 14 days to study (operated) eye	Drug: Matching Vehicle Placebo for APP13007, 0.05%; Matching vehicle placebo eye drop

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With ACC Count = 0 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.	Postoperative Day 8 and Postoperative Day 15
Participants With Ocular Pain Grade = 0 at All Visits From Postoperative Day 4 Through Postoperative Day 15 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; 1 = minimal; 2 = mild; 3 = moderate; 4 = severe pain).	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.	From First dose to Postoperative Day 22

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With Anterior Chamber Cell Grade = 0 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	Postoperative Day 8
Participants With Anterior Chamber Cell Grade = 0 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	Postoperative Day 15
Participants With Ocular Pain Grade = 0 at POD4 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).	Postoperative Day 4
Participants With Ocular Pain Grade = 0 at POD8 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).	Postoperative Day 8
Participants With Ocular Pain Grade = 0 at POD15 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).	Postoperative Day 15
Participants With Anterior Chamber Flare (ACF) = 0 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).	Postoperative Day 4
Participants With Anterior Chamber Flare (ACF) = 0 at POD8 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).	Postoperative Day 8
Participants With Anterior Chamber Flare (ACF) = 0 at POD15 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).	Postoperative Day 15
Anterior Chamber Cell Grade - 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	Baseline and Postoperative Day 15
Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD 15	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).	Baseline and Postoperative Day 15
Anterior Chamber Flare (ACF) - Change From Baseline (POD1 Prior to Dosing) to POD 15	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).	Baseline and Postoperative Day 15
Best Corrected Visual Acuity - 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.	Baseline and Postoperative Day 4
Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD8	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.	Baseline and Postoperative Day 8
Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD15	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.	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	First dose to Postoperative Day 15

Collaborators and Investigators

• Sponsor: Formosa Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): March 17, 2022
• Study Completion (Actual): March 17, 2022

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Lens Diseases; Inflammation; Cataract; Capsule Opacification
• Other Study ID Numbers: CPN-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No