Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study
- Conditions
- Ocular Inflammation and Pain After Cataract Surgery
- Interventions
- Drug: APP13007, 0.05%Drug: Matching Vehicle Placebo for APP13007, 0.05%
- Registration Number
- NCT04810962
- 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; POD1) after uncomplicated surgery for eligibility for randomization to study treatment. The study comprises the Main Study and the Endothelial Cell Sub-study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 370
- 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 APP13007 0.05% BID APP13007, 0.05% 1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye Matching Vehicle Placebo Matching Vehicle Placebo for APP13007, 0.05% 1 drop matching vehicle placebo twice daily for 14 days to study (operated) eye
- Primary Outcome Measures
Name Time Method Participants With ACC Count = 0 in the Operated Study Eye 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 in the Operated Study Eye 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 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).
Participants With Treatment-emergent Adverse Events (AEs) From First dose to Postoperative Day 22 (End of Main Study) Number of participants with ocular and systemic treatment-emergent AEs.
- Secondary Outcome Measures
Name Time Method Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye 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 in the Operated Study Eye at POD15 Without Rescue Medication Postoperative Day 15 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).
Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye 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 Ocular Pain Grade = 0 in the Operated Study Eye at POD4 Without Rescue Medication Postoperative Day 4 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).
Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye 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).
Ocular Pain Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15 Baseline and Postoperative Day 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).
Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye 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.
Anterior Chamber Cell Grade in the Operated Study Eye - 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 in the Operated Study Eye at POD8 Without Rescue Medication Postoperative Day 8 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).
Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye 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).
Anterior Chamber Flare (ACF) in the Operated Study Eye - 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; 1 = faint; 2 = moderate; 3 = marked; 4 = Intense).
Best Corrected Visual Acuity in the Operated Study Eye - 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.
Best Corrected Visual Acuity in the Operated Study Eye - 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.
Best Corrected Visual Acuity in the Operated Study Eye - 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.
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
Trial Locations
- Locations (31)
Premiere Practice Management, LLC
🇺🇸Los Angeles, California, United States
Wolstan and Goldberg Eye Associates
🇺🇸Torrance, California, United States
Round Rock Eye Consultants
🇺🇸Round Rock, Texas, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
Arizona Eye Center
🇺🇸Chandler, Arizona, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Alterman, Modi and Wolter
🇺🇸Poughkeepsie, New York, United States
Fraser Eye Center
🇺🇸Fraser, Michigan, United States
Wellish Vision Institute
🇺🇸Las Vegas, Nevada, United States
Metropolitan Eye Research and Surgery Institute
🇺🇸Palisades Park, New Jersey, United States
Stiles Eyecare Excellence and Glaucoma Institute, PA
🇺🇸Overland Park, Kansas, United States
Carrot Eye Center
🇺🇸Mesa, Arizona, United States
Orange County Ophthalmology Medical Group
🇺🇸Garden Grove, California, United States
LoBue Laser and Eye Medical Center Inc
🇺🇸Murrieta, California, United States
Visionary Research Institute
🇺🇸Newport Beach, California, United States
North Bay Eye Associates
🇺🇸Petaluma, California, United States
Michael K. Tran, MD, Inc.
🇺🇸Westminster, California, United States
Rand Eye Institute
🇺🇸Deerfield Beach, Florida, United States
Levenson Eye Associates
🇺🇸Jacksonville, Florida, United States
Eye Associates for Fort Myers
🇺🇸Fort Myers, Florida, United States
Dixon Eye Care
🇺🇸Albany, Georgia, United States
Clayton Eye Clinical Research LLC
🇺🇸Morrow, Georgia, United States
The Eye Care Center
🇺🇸Louisville, Kentucky, United States
Eye Care Specialists
🇺🇸Kingston, Pennsylvania, United States
DCT-Shah Research Institute LLC dba Discovery Clinical Trials
🇺🇸Mission, Texas, United States
Carolina Cataract and Laser Center
🇺🇸Ladson, South Carolina, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Chicago Cornea Consultants
🇺🇸Hoffman Estates, Illinois, United States
Ophthalmology Associates
🇺🇸Saint Louis, Missouri, United States
Cornea and Cataract Consultants of Arizona
🇺🇸Phoenix, Arizona, United States
International Research Center
🇺🇸Tampa, Florida, United States