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

Primary Purpose

Non-infectious Anterior Uveitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NS2
Prednisolone acetate ophthalmic suspension (1%)
Sponsored by
Aldeyra Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-infectious Anterior Uveitis focused on measuring uveitis, acute uveitis, anterior uveitis, NS2, Aldeyra, prednisolone acetate

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hull Eye Center
  • Colorado Retina Associates,PC
  • Eye Center of Southern Connecticut
  • Bascom Palmer Eye Institute
  • Valley Eye Physicians & Surgeons
  • Ophthalmic Consultants of Boston
  • Massachusetts Eye Research and Surgery Institution (MERSI)
  • Oakland Ophthalmic Surgery
  • Lifelong Vision Foundation
  • Tauber Eye Center
  • UNMC Stanley Truhlsen Eye Institute
  • Metropolitan Eye Research & Surgery Institute
  • Mid-Atlantic Retina
  • Houston Eye Associates
  • Virginia Eye Consultants

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

NS2

NS2 and Pred Forte

Pred Forte

Arm Description

NS2 ophthalmic drops (0.5%) in the affected eye

NS2 ophthalmic drops (0.5%) and Prednisolone acetate ophthalmic suspension (1%) in the affected eye

Prednisolone acetate ophthalmic suspension (1%) in the affected eye

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 26, 2015
Last Updated
March 1, 2023
Sponsor
Aldeyra Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02406209
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aldeyra Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-infectious Anterior Uveitis
Keywords
uveitis, acute uveitis, anterior uveitis, NS2, Aldeyra, prednisolone acetate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NS2
Arm Type
Experimental
Arm Description
NS2 ophthalmic drops (0.5%) in the affected eye
Arm Title
NS2 and Pred Forte
Arm Type
Experimental
Arm Description
NS2 ophthalmic drops (0.5%) and Prednisolone acetate ophthalmic suspension (1%) in the affected eye
Arm Title
Pred Forte
Arm Type
Active Comparator
Arm Description
Prednisolone acetate ophthalmic suspension (1%) in the affected eye
Intervention Type
Drug
Intervention Name(s)
NS2
Intervention Description
NS2 ophthalmic drops (0.5%)
Intervention Type
Drug
Intervention Name(s)
Prednisolone acetate ophthalmic suspension (1%)
Other Intervention Name(s)
Pred Forte
Primary Outcome Measure Information:
Title
Anterior Chamber Cell Grade at Week 8
Description
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.
Time Frame
The efficacy assessment period was assessed at Week 8; baseline was Day 1.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C.Stephen Foster, MD, FACS, FACR
Organizational Affiliation
Massachusetts Eye Research and Surgery Institution
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hull Eye Center
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Colorado Retina Associates,PC
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Eye Center of Southern Connecticut
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518-3144
Country
United States
Facility Name
Bascom Palmer Eye Institute
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Valley Eye Physicians & Surgeons
City
Ayer
State/Province
Massachusetts
ZIP/Postal Code
01940
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Massachusetts Eye Research and Surgery Institution (MERSI)
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Oakland Ophthalmic Surgery
City
Birmingham
State/Province
Michigan
ZIP/Postal Code
48009
Country
United States
Facility Name
Lifelong Vision Foundation
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Tauber Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
UNMC Stanley Truhlsen Eye Institute
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Metropolitan Eye Research & Surgery Institute
City
Palisades Park
State/Province
New Jersey
ZIP/Postal Code
07650
Country
United States
Facility Name
Mid-Atlantic Retina
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32955967
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.
Results Reference
derived

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

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