A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis
A Phase 2 Randomized, Investigator-Masked, Comparator-controlled Trial to Evaluate the Safety and Efficacy of NS2 Eye Drops in Patients With Anterior Uveitis
1 other identifier
interventional
45
1 country
15
Brief Summary
This is a randomized, multi-center, investigator masked, comparator controlled study. The purpose of this study is to determine the efficacy and safety of NS2 in patients with non-infectious acute anterior uveitis. Subjects will be randomized 1:1:1 to receive multiple doses of NS2 0.5%, NS2 0.5% and Pred Forte® 1%, or Pred Forte® 1%. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2015
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 26, 2015
CompletedFirst Posted
Study publicly available on registry
April 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
March 27, 2023
CompletedMarch 27, 2023
February 1, 2019
1.1 years
March 26, 2015
February 27, 2023
March 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anterior Chamber Cell Grade at Week 8
Change from baseline comparison of NS2 ophthalmic drops (0.5%), NS2 (0.5%) and Pred Forte® (0.1%) ophthalmic drops, and Pred Forte® (1%) ophthalmic drops on an anterior chamber cell grade scale of 0 to 4 (0 = absent, 4 = severe). The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor.
The efficacy assessment period was assessed at Week 8; baseline was Day 1.
Study Arms (3)
NS2
EXPERIMENTALNS2 ophthalmic drops (0.5%) in the affected eye
NS2 and Pred Forte
EXPERIMENTALNS2 ophthalmic drops (0.5%) and Prednisolone acetate ophthalmic suspension (1%) in the affected eye
Pred Forte
ACTIVE COMPARATORPrednisolone acetate ophthalmic suspension (1%) in the affected eye
Interventions
Eligibility Criteria
You may qualify if:
- Non-infectious anterior uveitis
- 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
You may not qualify if:
- Severe/serious ocular pathology
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Hull Eye Center
Lancaster, California, 93534, United States
Colorado Retina Associates,PC
Golden, Colorado, 80401, United States
Eye Center of Southern Connecticut
Hamden, Connecticut, 06518-3144, United States
Bascom Palmer Eye Institute
Plantation, Florida, 33324, United States
Valley Eye Physicians & Surgeons
Ayer, Massachusetts, 01940, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Massachusetts Eye Research and Surgery Institution (MERSI)
Waltham, Massachusetts, 02451, United States
Oakland Ophthalmic Surgery
Birmingham, Michigan, 48009, United States
Lifelong Vision Foundation
Chesterfield, Missouri, 63017, United States
Tauber Eye Center
Kansas City, Missouri, 64111, United States
UNMC Stanley Truhlsen Eye Institute
Omaha, Nebraska, 68106, United States
Metropolitan Eye Research & Surgery Institute
Palisades Park, New Jersey, 07650, United States
Mid-Atlantic Retina
Philadelphia, Pennsylvania, 19107, United States
Houston Eye Associates
Houston, Texas, 77025, United States
Virginia Eye Consultants
Norfolk, Virginia, 23502, United States
Related Publications (1)
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.
PMID: 32955967DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. Director, Clinical Operations
- Organization
- Aldeyra Therapeutics, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
C.Stephen Foster, MD, FACS, FACR
Massachusetts Eye Research and Surgery Institution
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2015
First Posted
April 2, 2015
Study Start
March 1, 2015
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
March 27, 2023
Results First Posted
March 27, 2023
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share