Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery
NCT ID: NCT04739709
Last Updated: 2023-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
378 participants
INTERVENTIONAL
2021-01-11
2022-03-17
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 place 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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Locations
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Schwartz Laser Eye Center
Scottsdale, Arizona, 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
North Valley Eye Medical Group, Inc.
Mission Hills, California, United States
LoBue Laser and Eye Medical Center, Inc.
Murrieta, California, United States
Pendleton Eye Center
Oceanside, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Shasta Eye Medical Group, Inc.
Redding, California, United States
Icon Eye Care
Grand Junction, Colorado, United States
Levenson Eye Associates
Jacksonville, Florida, United States
International Eye Associates, PA
Ormond Beach, Florida, United States
Newsom Eye and Laser Center
Sebring, Florida, United States
Coastal Research Associates, LLC
Roswell, Georgia, United States
Jacksoneye SC
Columbus, Illinois, United States
Midwest Cornea Associates, LLC
Carmel, Indiana, United States
Senior Health Services
Louisville, Kentucky, United States
Silverstein Eye Centers, PC
Kansas City, Missouri, United States
Ophthalmology Consultants, Ltd.
St Louis, Missouri, United States
Comprehensive Eye Care, Ltd.
Washington, Missouri, United States
NV Eye Surgery
Henderson, Nevada, United States
Center For Sight
Las Vegas, Nevada, United States
Raymond Fong, MD, PC
New York, New York, United States
Carolina Eye Associates
Southern Pines, North Carolina, United States
Eye Physicians, LLC
Columbus, Ohio, United States
Bucci Laser Vision Institute
Wilkes-Barre, Pennsylvania, United States
Keystone Research Ltd.
Austin, Texas, United States
Retina Research Center, PLLC
Austin, Texas, United States
Houston Eye Associates
Houston, Texas, United States
Advanced Laser Vision and Surgical Institute
Houston, Texas, United States
Lake Travis Eye and Laser Center
Lakeway, Texas, 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
Centro Oftalmologico Metropolitano
San Juan, , Puerto Rico
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-301
Identifier Type: -
Identifier Source: org_study_id
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