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SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.

Primary Purpose

Non-infectious Anterior Uveitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ADX-102 Ophthalmic Solution (0.5%)
Vehicle of ADX-102 Ophthalmic Solution
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 reproxalap

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female subjects aged ≥ 18 years and ≤ 85 years.
  • Subjects with acute non-infectious anterior uveitis with onset of symptoms within the previous 2 weeks.
  • Best corrected visual acuity (BCVA) better than or equal to 35 letters in the study eye and 65 letters in the non-study eye using ETDRS testing.

Exclusion Criteria:

  • Have severe/serious ocular pathology in the study eye(s) which may preclude study completion, in the judgement of the Investigator.
  • Active intermediate or posterior uveitis in the study eye(s).
  • Previous anterior uveitis episode in the study eye ≤ 4 weeks prior to screening.
  • Have participated in another investigational device or drug study within 30 days prior to screening.
  • Participation in a prior ADX-102 study.

Sites / Locations

  • UAB Department of Ophthalmology
  • Retinal Research Institute
  • M&M Eye Institute
  • Walman Eye Center
  • Retina-Vitreous Associates Medical Group
  • University of California, Irvine
  • Byers Eye Institute at Stanford University
  • Retinal Consultants Medical Group, Inc.
  • Corneal Consultants of Colorado
  • Danbury Eye Physicians & Surgeons
  • Levenson Eye Associates
  • Center for Retina and Macular Disease
  • Midwest Eye Institute
  • John Hopkins
  • Valley Eye Physicians & Surgeons
  • Ophthalmic Consultants of Boston
  • Ocular Immunology & Uveitis Foundation
  • Oakland Ophthalmic Surgery
  • Tauber Eye Center
  • Metropolitan Eye Research and Surgery Institute
  • Bergstrom Eye Research
  • Oregon Retina, LLP
  • Texas Retina Associates
  • Retina Consultants of Houston
  • Retina and Uveitis Consultants of Texas
  • Retina Consultants of Houston
  • Virginia Eye Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ADX-102 Ophthalmic Solution (0.5%)

Vehicle of ADX-102 Ophthalmic Solution

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of ADX-102 on anterior chamber cell count using an anterior uveitis grading scale.
Evaluate the efficacy of ADX-102 Ophthalmic Solution on anterior chamber cell count in subjects with non-infectious anterior uveitis.

Secondary Outcome Measures

Efficacy of ADX-102 on anterior chamber flare using an anterior uveitis grading scale.
Evaluate the signs and symptoms of ADX-102 Ophthalmic Solution on anterior chamber flare in subjects with non-infectious anterior uveitis.

Full Information

First Posted
April 4, 2017
Last Updated
May 15, 2020
Sponsor
Aldeyra Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03131154
Brief Title
SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.
Official Title
A Phase 3, Randomized, Double-masked, Vehicle-controlled Trial to Evaluate the Safety and Efficacy of ADX-102 Ophthalmic Solution in Subjects With Non-infectious Anterior-uveitis.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 26, 2017 (Actual)
Primary Completion Date
April 19, 2019 (Actual)
Study Completion Date
April 26, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Phase 3, randomized, double-masked, vehicle-controlled trial to evaluate the safety and efficacy of ADX-102 ophthalmic solution in Subjects with non-infectious anterior-uveitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-infectious Anterior Uveitis
Keywords
reproxalap

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADX-102 Ophthalmic Solution (0.5%)
Arm Type
Experimental
Arm Title
Vehicle of ADX-102 Ophthalmic Solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ADX-102 Ophthalmic Solution (0.5%)
Other Intervention Name(s)
Reproxalap
Intervention Description
ADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks.
Intervention Type
Drug
Intervention Name(s)
Vehicle of ADX-102 Ophthalmic Solution
Other Intervention Name(s)
Vehicle of Reproxlap
Intervention Description
Vehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks.
Primary Outcome Measure Information:
Title
Efficacy of ADX-102 on anterior chamber cell count using an anterior uveitis grading scale.
Description
Evaluate the efficacy of ADX-102 Ophthalmic Solution on anterior chamber cell count in subjects with non-infectious anterior uveitis.
Time Frame
Efficacy assessment period (Day 1 through Day 29)
Secondary Outcome Measure Information:
Title
Efficacy of ADX-102 on anterior chamber flare using an anterior uveitis grading scale.
Description
Evaluate the signs and symptoms of ADX-102 Ophthalmic Solution on anterior chamber flare in subjects with non-infectious anterior uveitis.
Time Frame
Efficacy assessment period (Day 1 through Day 29)

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: Male or female subjects aged ≥ 18 years and ≤ 85 years. Subjects with acute non-infectious anterior uveitis with onset of symptoms within the previous 2 weeks. Best corrected visual acuity (BCVA) better than or equal to 35 letters in the study eye and 65 letters in the non-study eye using ETDRS testing. Exclusion Criteria: Have severe/serious ocular pathology in the study eye(s) which may preclude study completion, in the judgement of the Investigator. Active intermediate or posterior uveitis in the study eye(s). Previous anterior uveitis episode in the study eye ≤ 4 weeks prior to screening. Have participated in another investigational device or drug study within 30 days prior to screening. Participation in a prior ADX-102 study.
Facility Information:
Facility Name
UAB Department of Ophthalmology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Retinal Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
M&M Eye Institute
City
Prescott
State/Province
Arizona
ZIP/Postal Code
86301
Country
United States
Facility Name
Walman Eye Center
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Byers Eye Institute at Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
85014
Country
United States
Facility Name
Retinal Consultants Medical Group, Inc.
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Corneal Consultants of Colorado
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Danbury Eye Physicians & Surgeons
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Levenson Eye Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
33204
Country
United States
Facility Name
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
John Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Valley Eye Physicians & Surgeons
City
Ayer
State/Province
Massachusetts
ZIP/Postal Code
01432
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Ocular Immunology & Uveitis Foundation
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
Tauber Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Metropolitan Eye Research and Surgery Institute
City
Palisades Park
State/Province
New Jersey
ZIP/Postal Code
07650
Country
United States
Facility Name
Bergstrom Eye Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Oregon Retina, LLP
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Retina Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Retina and Uveitis Consultants of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retina Consultants of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
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

Learn more about this trial

SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.

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