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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03131154
Recruitment Status : Completed
First Posted : April 27, 2017
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Aldeyra Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Non-infectious Anterior Uveitis Drug: ADX-102 Ophthalmic Solution (0.5%) Drug: Vehicle of ADX-102 Ophthalmic Solution Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : April 26, 2017
Actual Primary Completion Date : April 19, 2019
Actual Study Completion Date : April 26, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ADX-102 Ophthalmic Solution (0.5%) Drug: ADX-102 Ophthalmic Solution (0.5%)
ADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks.

Placebo Comparator: Vehicle of ADX-102 Ophthalmic Solution Drug: Vehicle of ADX-102 Ophthalmic Solution
Vehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks.




Primary Outcome Measures :
  1. Efficacy of ADX-102 on anterior chamber cell count using an anterior uveitis grading scale. [ Time Frame: Efficacy assessment period (Day 1 through Day 29) ]
    Evaluate the efficacy of ADX-102 Ophthalmic Solution on anterior chamber cell count in subjects with non-infectious anterior uveitis.


Secondary Outcome Measures :
  1. Efficacy of ADX-102 on anterior chamber flare using an anterior uveitis grading scale. [ Time Frame: Efficacy assessment period (Day 1 through Day 29) ]
    Evaluate the signs and symptoms of ADX-102 Ophthalmic Solution on anterior chamber flare in subjects with non-infectious anterior uveitis.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131154


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Locations
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United States, Alabama
UAB Department of Ophthalmology
Birmingham, Alabama, United States, 35233
United States, Arizona
Retinal Research Institute
Phoenix, Arizona, United States, 85014
M&M Eye Institute
Prescott, Arizona, United States, 86301
Walman Eye Center
Sun City, Arizona, United States, 85351
United States, California
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
University of California, Irvine
Irvine, California, United States, 92697
Byers Eye Institute at Stanford University
Palo Alto, California, United States, 85014
Retinal Consultants Medical Group, Inc.
Sacramento, California, United States, 95819
United States, Colorado
Corneal Consultants of Colorado
Littleton, Colorado, United States, 80120
United States, Connecticut
Danbury Eye Physicians & Surgeons
Danbury, Connecticut, United States, 06810
United States, Florida
Levenson Eye Associates
Jacksonville, Florida, United States, 33204
Center for Retina and Macular Disease
Winter Haven, Florida, United States, 33880
United States, Indiana
Midwest Eye Institute
Indianapolis, Indiana, United States, 46290
United States, Maryland
John Hopkins
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Valley Eye Physicians & Surgeons
Ayer, Massachusetts, United States, 01432
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Ocular Immunology & Uveitis Foundation
Waltham, Massachusetts, United States, 02451
United States, Michigan
Oakland Ophthalmic Surgery
Birmingham, Michigan, United States, 48009
United States, Missouri
Tauber Eye Center
Kansas City, Missouri, United States, 64111
United States, New Jersey
Metropolitan Eye Research and Surgery Institute
Palisades Park, New Jersey, United States, 07650
United States, North Dakota
Bergstrom Eye Research
Fargo, North Dakota, United States, 58103
United States, Oregon
Oregon Retina, LLP
Eugene, Oregon, United States, 97401
United States, Texas
Texas Retina Associates
Dallas, Texas, United States, 75231
Retina Consultants of Houston
Houston, Texas, United States, 77030
Retina and Uveitis Consultants of Texas
San Antonio, Texas, United States, 78240
Retina Consultants of Houston
The Woodlands, Texas, United States, 77384
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Aldeyra Therapeutics, Inc.

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Responsible Party: Aldeyra Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03131154     History of Changes
Other Study ID Numbers: ADX-102-UV-005
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aldeyra Therapeutics, Inc.:
reproxalap
Additional relevant MeSH terms:
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Uveitis
Uveitis, Anterior
Iridocyclitis
Uveal Diseases
Eye Diseases
Panuveitis
Iris Diseases
Ophthalmic Solutions
Pharmaceutical Solutions