A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery
NCT ID: NCT04089735
Last Updated: 2023-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
165 participants
INTERVENTIONAL
2019-08-13
2020-04-07
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% twice daily (BID) [Part A]
1 drop 0.05% APP13007 twice daily for 21 days to the operated eye
APP13007, 0.05%
APP13007 eye drop, 0.05%
APP13007 0.05% Placebo twice daily (BID) [Part A]
1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye
APP13007 Placebo, 0.05%
APP13007 placebo eyedrop, 0.05%
APP13007 0.05% twice daily (BID) and once daily (QD) [Part B]
1 drop 0.05% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye
APP13007, 0.05%
APP13007 eye drop, 0.05%
APP13007 0.05% Placebo twice daily (BID) and once daily (QD) [Part B]
1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye
APP13007 Placebo, 0.05%
APP13007 placebo eyedrop, 0.05%
APP13007 0.1% twice daily (BID) and once daily (QD) [Part B]
1 drop 0.1% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye
APP13007, 0.1%
APP13007 eye drop, 0.1%
APP13007 0.1% Placebo twice daily (BID) and once daily (QD) [Part B]
1 drop matching vehicle placebo for 0.1% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye
APP13007 Placebo, 0.1%
APP13007 placebo eyedrop, 0.1%
Interventions
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APP13007, 0.05%
APP13007 eye drop, 0.05%
APP13007, 0.1%
APP13007 eye drop, 0.1%
APP13007 Placebo, 0.05%
APP13007 placebo eyedrop, 0.05%
APP13007 Placebo, 0.1%
APP13007 placebo eyedrop, 0.1%
Eligibility Criteria
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Inclusion Criteria
* In Investigator's opinion, have Early Treatment Diabetic Retinopathy Study estimated potential of 0.7 (20/100) or better in study eye.
* Have \> 10 and ≤ 30 cells in anterior chamber.
* Have an intraocular pressure ≤ 30 mmHg.
Exclusion Criteria
* Have a score \> 0 on Ocular Pain Assessment in either eye.
50 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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Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, United States
United Medical Research Institute
Inglewood, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Levenson Eye Associates
Jacksonville, Florida, United States
Bowden Eye and Associates
Jacksonville, Florida, United States
Ophthalmology Associates
St Louis, Missouri, United States
Eye Care Specialists
Kingston, Pennsylvania, United States
Keystone Research Ltd.
Austin, Texas, United States
Cataract & Glaucoma Center
El Paso, 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-201
Identifier Type: -
Identifier Source: org_study_id
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