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

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, Including a Corneal Endothelial Cell Sub-study

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 Overview

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

• Study Type: Interventional
• Enrollment (Actual): 370
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Ops Representative; Phone Number: 919-797-1146; Email: clin.ops@aimmaxrx.com

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Arizona Eye Center
    • Mesa, Arizona, United States, 85260
      • Carrot Eye Center
    • Phoenix, Arizona, United States, 85032
      • Cornea and Cataract Consultants of Arizona
  • California
    • Garden Grove, California, United States, 92843
      • Orange County Ophthalmology Medical Group
    • Los Angeles, California, United States, 90013
      • Premiere Practice Management, LLC
    • Murrieta, California, United States, 92562
      • LoBue Laser and Eye Medical Center Inc
    • Newport Beach, California, United States, 92663
      • Visionary Research Institute
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates
    • Torrance, California, United States, 90505
      • Wolstan and Goldberg Eye Associates
    • Westminster, California, United States, 92683
      • Michael K. Tran, MD, Inc.
  • Florida
    • Deerfield Beach, Florida, United States, 33064
      • Rand Eye Institute
    • Fort Myers, Florida, United States, 33901
      • Eye Associates for Fort Myers
    • Jacksonville, Florida, United States, 32204
      • Levenson Eye Associates
    • Tampa, Florida, United States, 33603
      • International Research Center
  • Georgia
    • Albany, Georgia, United States, 31701
      • Dixon Eye Care
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Clinical Research LLC
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Chicago Cornea Consultants
  • Kansas
    • Overland Park, Kansas, United States, 66213
      • Stiles Eyecare Excellence and Glaucoma Institute, PA
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • The Eye Care Center
  • Michigan
    • Fraser, Michigan, United States, 48026
      • Fraser Eye Center
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Associates
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Wellish Vision Institute
  • New Jersey
    • Palisades Park, New Jersey, United States, 07650
      • Metropolitan Eye Research and Surgery Institute
  • New York
    • Poughkeepsie, New York, United States, 12603
      • Alterman, Modi and Wolter
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Eye Institute
  • Pennsylvania
    • Kingston, Pennsylvania, United States, 18704
      • Eye Care Specialists
  • South Carolina
    • Ladson, South Carolina, United States, 29456
      • Carolina Cataract and Laser Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Regional Eye Institute
  • Texas
    • Houston, Texas, United States, 70025
      • Houston Eye Associates
    • Mission, Texas, United States, 78572
      • DCT-Shah Research Institute LLC dba Discovery Clinical Trials
    • Round Rock, Texas, United States, 78681
      • Round Rock Eye Consultants

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 placebo 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 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.	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).	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 (End of Main Study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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).	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).	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).	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).	Postoperative Day 4
Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye 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 in the Operated Study Eye 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 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	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).	Baseline and Postoperative Day 15
Anterior Chamber Flare (ACF) in the Operated Study Eye - 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; 1 = faint; 2 = moderate; 3 = marked; 4 = Intense).	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.	Baseline and Postoperative Day 4
Best Corrected Visual Acuity in the Operated Study Eye - 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 in the Operated Study Eye - 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 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.	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.	Postoperative Day 15

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Endothelial Cell Density - Mean Change From Screening to Postoperative Day 85	Corneal endothelial cell density in the Operated Study Eye (units: cells/mm2) was measured from the corneal endothelial cell images obtained using a specular microscope.	Screening and Postoperative Day 85

Collaborators and Investigators

• Sponsor: Formosa Pharmaceuticals, Inc.
• Investigators: Study Director: Chief Medical Officer, AimMax Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Actual): July 6, 2022
• Study Completion (Actual): July 6, 2022

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 12, 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-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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