A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis

Non-infectious Anterior Uveitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406209
• Other study ID #: NS2-02
• Status: Completed
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: April 2016

Study information

• Verified date: February 2019
• Source: Aldeyra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Iridocyclitis
• Non-infectious Anterior Uveitis
• Uveitis
• Uveitis, Anterior

Intervention

Drug:
• NS2
NS2 ophthalmic drops (0.5%)
• Prednisolone acetate ophthalmic suspension (1%)

Locations

Country	Name	City	State
United States	Valley Eye Physicians & Surgeons	Ayer	Massachusetts
United States	Oakland Ophthalmic Surgery	Birmingham	Michigan
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Lifelong Vision Foundation	Chesterfield	Missouri
United States	Colorado Retina Associates,PC	Golden	Colorado
United States	Eye Center of Southern Connecticut	Hamden	Connecticut
United States	Houston Eye Associates	Houston	Texas
United States	Tauber Eye Center	Kansas City	Missouri
United States	Hull Eye Center	Lancaster	California
United States	Virginia Eye Consultants	Norfolk	Virginia
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	Bascom Palmer Eye Institute	Plantation	Florida
United States	Massachusetts Eye Research and Surgery Institution (MERSI)	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Aldeyra Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.