Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study
NCT ID: NCT04810962
Last Updated: 2023-07-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
370 participants
INTERVENTIONAL
2021-03-16
2022-07-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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APP13007 0.05% BID
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%
APP13007 eye drop, 0.05%
Matching Vehicle Placebo
1 drop matching vehicle placebo twice daily for 14 days to study (operated) eye
Matching Vehicle Placebo for APP13007, 0.05%
Matching vehicle placebo eye drop
Interventions
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APP13007, 0.05%
APP13007 eye drop, 0.05%
Matching Vehicle Placebo for APP13007, 0.05%
Matching vehicle placebo eye drop
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Formosa Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
AimMax Therapeutics Inc.
Locations
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Arizona Eye Center
Chandler, Arizona, United States
Carrot Eye Center
Mesa, Arizona, United States
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, United States
Orange County Ophthalmology Medical Group
Garden Grove, California, United States
Premiere Practice Management, LLC
Los Angeles, 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
Wolstan and Goldberg Eye Associates
Torrance, California, United States
Michael K. Tran, MD, Inc.
Westminster, California, United States
Rand Eye Institute
Deerfield Beach, Florida, United States
Eye Associates for Fort Myers
Fort Myers, Florida, United States
Levenson Eye Associates
Jacksonville, Florida, United States
International Research Center
Tampa, Florida, United States
Dixon Eye Care
Albany, Georgia, United States
Clayton Eye Clinical Research LLC
Morrow, Georgia, United States
Chicago Cornea Consultants
Hoffman Estates, Illinois, United States
Stiles Eyecare Excellence and Glaucoma Institute, PA
Overland Park, Kansas, United States
The Eye Care Center
Louisville, Kentucky, United States
Fraser Eye Center
Fraser, Michigan, United States
Ophthalmology Associates
St Louis, Missouri, United States
Wellish Vision Institute
Las Vegas, Nevada, United States
Metropolitan Eye Research and Surgery Institute
Palisades Park, New Jersey, United States
Alterman, Modi and Wolter
Poughkeepsie, New York, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Eye Care Specialists
Kingston, Pennsylvania, United States
Carolina Cataract and Laser Center
Ladson, South Carolina, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Houston Eye Associates
Houston, Texas, United States
DCT-Shah Research Institute LLC dba Discovery Clinical Trials
Mission, Texas, United States
Round Rock Eye Consultants
Round Rock, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CPN-302
Identifier Type: -
Identifier Source: org_study_id
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