Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery
- Conditions
- Ocular Inflammation and Pain
- Interventions
- Drug: Matching Vehicle Placebo for APP13007, 0.05%Drug: APP13007, 0.05%
- Registration Number
- NCT04739709
- Lead Sponsor
- Formosa Pharmaceuticals, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 378
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Matching Vehicle Placebo Matching Vehicle Placebo for APP13007, 0.05% 1 drop matching vehicle place twice daily for 14 days to study (operated) eye APP13007 0.05% BID APP13007, 0.05% 1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
- Primary Outcome Measures
Name Time Method Participants With ACC Count = 0 at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication Postoperative Day 8 and Postoperative Day 15 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.
Participants With Ocular Pain Grade = 0 at All Visits From Postoperative Day 4 Through Postoperative Day 15 Without Rescue Medication Postoperative Day 4, Postoperative Day 8 and Postoperative Day 15 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).
Participants With Treatment-emergent Adverse Events (AEs) From First dose to Postoperative Day 22 Number of participants with ocular and systemic treatment-emergent AEs.
- Secondary Outcome Measures
Name Time Method Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD 15 Baseline and Postoperative Day 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).
Participants With Anterior Chamber Flare (ACF) = 0 at POD4 Without Rescue Medication Postoperative Day 4 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).
Participants With Anterior Chamber Cell Grade = 0 at POD8 Without Rescue Medication Postoperative Day 8 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
Participants With Anterior Chamber Cell Grade = 0 at POD15 Without Rescue Medication Postoperative Day 15 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
Participants With Ocular Pain Grade = 0 at POD4 Without Rescue Medication Postoperative Day 4 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).
Participants With Ocular Pain Grade = 0 at POD8 Without Rescue Medication Postoperative Day 8 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).
Anterior Chamber Cell Grade - Change From Baseline (POD1 Prior to Dosing) to POD 15 Baseline and Postoperative Day 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
Participants With Ocular Pain Grade = 0 at POD15 Without Rescue Medication Postoperative Day 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).
Participants With Anterior Chamber Flare (ACF) = 0 at POD8 Without Rescue Medication Postoperative Day 8 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).
Participants With Anterior Chamber Flare (ACF) = 0 at POD15 Without Rescue Medication Postoperative Day 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).
Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD8 Baseline and Postoperative Day 8 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.
Participants Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment First dose to Postoperative Day 15 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
Anterior Chamber Flare (ACF) - Change From Baseline (POD1 Prior to Dosing) to POD 15 Baseline and Postoperative Day 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).
Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD4 Baseline and Postoperative Day 4 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.Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD15 Baseline and Postoperative Day 15 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.
Trial Locations
- Locations (35)
Houston Eye Associates
🇺🇸Houston, Texas, United States
Midwest Cornea Associates, LLC
🇺🇸Carmel, Indiana, United States
Eye Physicians, LLC
🇺🇸Columbus, Ohio, United States
Carolina Eye Associates
🇺🇸Southern Pines, North Carolina, United States
Jacksoneye SC
🇺🇸Columbus, Illinois, United States
Lake Travis Eye and Laser Center
🇺🇸Lakeway, Texas, United States
Global Research Management
🇺🇸Glendale, California, United States
Inland Eye Specialists
🇺🇸Hemet, California, United States
SoCal Eye Physicians and Associates
🇺🇸Long Beach, California, United States
Newsom Eye and Laser Center
🇺🇸Sebring, Florida, United States
Coastal Research Associates, LLC
🇺🇸Roswell, Georgia, United States
Comprehensive Eye Care, Ltd.
🇺🇸Washington, Missouri, United States
North Valley Eye Medical Group, Inc.
🇺🇸Mission Hills, California, United States
Shasta Eye Medical Group, Inc.
🇺🇸Redding, California, United States
Bucci Laser Vision Institute
🇺🇸Wilkes-Barre, Pennsylvania, United States
Advanced Laser Vision and Surgical Institute
🇺🇸Houston, Texas, United States
Ophthalmology Consultants, Ltd.
🇺🇸Saint Louis, Missouri, United States
Schwartz Laser Eye Center
🇺🇸Scottsdale, Arizona, United States
LoBue Laser and Eye Medical Center, Inc.
🇺🇸Murrieta, California, United States
Icon Eye Care
🇺🇸Grand Junction, Colorado, United States
International Eye Associates, PA
🇺🇸Ormond Beach, Florida, United States
Pendleton Eye Center
🇺🇸Oceanside, California, United States
Martel Eye Medical Group
🇺🇸Rancho Cordova, California, United States
Levenson Eye Associates
🇺🇸Jacksonville, Florida, United States
Raymond Fong, MD, PC
🇺🇸New York, New York, United States
Centro Oftalmologico Metropolitano
🇵🇷San Juan, Puerto Rico
Senior Health Services
🇺🇸Louisville, Kentucky, United States
Silverstein Eye Centers, PC
🇺🇸Kansas City, Missouri, United States
Center For Sight
🇺🇸Las Vegas, Nevada, United States
R and R Eye Research, LLC
🇺🇸San Antonio, Texas, United States
San Antonio Eye Center
🇺🇸San Antonio, Texas, United States
Stacy R. Smith, MD, PC
🇺🇸Salt Lake City, Utah, United States
NV Eye Surgery
🇺🇸Henderson, Nevada, United States
Keystone Research Ltd.
🇺🇸Austin, Texas, United States
Retina Research Center, PLLC
🇺🇸Austin, Texas, United States