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

Ocular Inflammation and Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04739709
• Other study ID #: CPN-301
• Status: Completed
• Phase: Phase 3
• Start date: January 11, 2021
• Est. completion date: March 17, 2022

Study information

• Verified date: July 2023
• Source: Formosa Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: March 17, 2022
• Est. primary completion date: March 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Inflammation
• Ocular Inflammation and Pain

Intervention

Drug:
• APP13007, 0.05%
APP13007 eye drop, 0.05%
• Matching Vehicle Placebo for APP13007, 0.05%
Matching vehicle placebo eye drop

Locations

Country	Name	City	State
Puerto Rico	Centro Oftalmologico Metropolitano	San Juan
United States	Keystone Research Ltd.	Austin	Texas
United States	Retina Research Center, PLLC	Austin	Texas
United States	Midwest Cornea Associates, LLC	Carmel	Indiana
United States	Eye Physicians, LLC	Columbus	Ohio
United States	Jacksoneye SC	Columbus	Illinois
United States	Global Research Management	Glendale	California
United States	Icon Eye Care	Grand Junction	Colorado
United States	Inland Eye Specialists	Hemet	California
United States	NV Eye Surgery	Henderson	Nevada
United States	Advanced Laser Vision and Surgical Institute	Houston	Texas
United States	Houston Eye Associates	Houston	Texas
United States	Levenson Eye Associates	Jacksonville	Florida
United States	Silverstein Eye Centers, PC	Kansas City	Missouri
United States	Lake Travis Eye and Laser Center	Lakeway	Texas
United States	Center For Sight	Las Vegas	Nevada
United States	SoCal Eye Physicians and Associates	Long Beach	California
United States	Senior Health Services	Louisville	Kentucky
United States	North Valley Eye Medical Group, Inc.	Mission Hills	California
United States	LoBue Laser and Eye Medical Center, Inc.	Murrieta	California
United States	Raymond Fong, MD, PC	New York	New York
United States	Pendleton Eye Center	Oceanside	California
United States	International Eye Associates, PA	Ormond Beach	Florida
United States	Martel Eye Medical Group	Rancho Cordova	California
United States	Shasta Eye Medical Group, Inc.	Redding	California
United States	Coastal Research Associates, LLC	Roswell	Georgia
United States	Ophthalmology Consultants, Ltd.	Saint Louis	Missouri
United States	Stacy R. Smith, MD, PC	Salt Lake City	Utah
United States	R and R Eye Research, LLC	San Antonio	Texas
United States	San Antonio Eye Center	San Antonio	Texas
United States	Schwartz Laser Eye Center	Scottsdale	Arizona
United States	Newsom Eye and Laser Center	Sebring	Florida
United States	Carolina Eye Associates	Southern Pines	North Carolina
United States	Comprehensive Eye Care, Ltd.	Washington	Missouri
United States	Bucci Laser Vision Institute	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Formosa Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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