Clinical trial NCT02406209: A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis
Official title: A Phase 2 Randomized, Investigator-Masked, Comparator-controlled Trial to Evaluate the Safety and Efficacy of NS2 Eye Drops in Patients With Anterior Uveitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-infectious Anterior Uveitis
Keywords: uveitis
acute uveitis
anterior uveitis
NS2
Aldeyra
prednisolone acetate
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Anterior Chamber Cell Grade at Week 8
timeFrame: The efficacy assessment period was assessed at Week 8; baseline was Day 1.
Secondary outcomes:
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Hull Eye Center
state: California
city: Golden
country: United States
facility: Colorado Retina Associates,PC
state: Colorado
city: Hamden
country: United States
facility: Eye Center of Southern Connecticut
state: Connecticut
city: Plantation
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Ayer
country: United States
facility: Valley Eye Physicians & Surgeons
state: Massachusetts
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Waltham
country: United States
facility: Massachusetts Eye Research and Surgery Institution (MERSI)
state: Massachusetts
city: Birmingham
country: United States
facility: Oakland Ophthalmic Surgery
state: Michigan
city: Chesterfield
country: United States
facility: Lifelong Vision Foundation
state: Missouri
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Omaha
country: United States
facility: UNMC Stanley Truhlsen Eye Institute
state: Nebraska
city: Palisades Park
country: United States
facility: Metropolitan Eye Research & Surgery Institute
state: New Jersey
city: Philadelphia
country: United States
facility: Mid-Atlantic Retina
state: Pennsylvania
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
affiliation: Massachusetts Eye Research and Surgery Institution
name: C.Stephen Foster, MD, FACS, FACR
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.