A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis
NCT ID: NCT02406209
Last Updated: 2023-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
45 participants
INTERVENTIONAL
2015-03-31
2016-04-30
Brief Summary
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Free aldehydes are thought to be related to inflammatory diseases such as uveitis. NS2, a small molecule aldehyde trap, may decrease inflammation by lowering aldehyde levels.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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NS2
NS2 ophthalmic drops (0.5%) in the affected eye
NS2
NS2 ophthalmic drops (0.5%)
NS2 and Pred Forte
NS2 ophthalmic drops (0.5%) and Prednisolone acetate ophthalmic suspension (1%) in the affected eye
NS2
NS2 ophthalmic drops (0.5%)
Prednisolone acetate ophthalmic suspension (1%)
Pred Forte
Prednisolone acetate ophthalmic suspension (1%) in the affected eye
Prednisolone acetate ophthalmic suspension (1%)
Interventions
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NS2
NS2 ophthalmic drops (0.5%)
Prednisolone acetate ophthalmic suspension (1%)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Grade 1 - Grade 3 anterior chamber cell count
* Subjects must have Intraocular pressure \<25 mmHg at baseline and may only administer a maximum of 1 topical medication to control Intraocular pressure in the study eye.
* Visual acuity ≥ 20/200 in the study eye
Exclusion Criteria
* Active intermediate or posterior uveitis.
* Previous anterior uveitis episode in the study eye within 4 weeks of Visit 1
* Oral corticosteroids within 14 days of Visit 1
* Intravitreal or sub-Tenon corticosteroid treatment in the study eye within the past 6 months.
18 Years
85 Years
ALL
No
Sponsors
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Aldeyra Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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C.Stephen Foster, MD, FACS, FACR
Role: PRINCIPAL_INVESTIGATOR
Massachusetts Eye Research and Surgery Institution
Locations
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Hull Eye Center
Lancaster, California, United States
Colorado Retina Associates,PC
Golden, Colorado, United States
Eye Center of Southern Connecticut
Hamden, Connecticut, United States
Bascom Palmer Eye Institute
Plantation, Florida, United States
Valley Eye Physicians & Surgeons
Ayer, Massachusetts, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Massachusetts Eye Research and Surgery Institution (MERSI)
Waltham, Massachusetts, United States
Oakland Ophthalmic Surgery
Birmingham, Michigan, United States
Lifelong Vision Foundation
Chesterfield, Missouri, United States
Tauber Eye Center
Kansas City, Missouri, United States
UNMC Stanley Truhlsen Eye Institute
Omaha, Nebraska, United States
Metropolitan Eye Research & Surgery Institute
Palisades Park, New Jersey, United States
Mid-Atlantic Retina
Philadelphia, Pennsylvania, United States
Houston Eye Associates
Houston, Texas, United States
Virginia Eye Consultants
Norfolk, Virginia, United States
Countries
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References
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Mandell KJ, Clark D, Chu DS, Foster CS, Sheppard J, Brady TC. Randomized Phase 2 Trial of Reproxalap, a Novel Reactive Aldehyde Species Inhibitor, in Patients with Noninfectious Anterior Uveitis: Model for Corticosteroid Replacement. J Ocul Pharmacol Ther. 2020 Dec;36(10):732-739. doi: 10.1089/jop.2020.0056. Epub 2020 Sep 22.
Other Identifiers
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NS2-02
Identifier Type: -
Identifier Source: org_study_id
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