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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 : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Aldeyra Therapeutics, Inc.

Study Description
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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

Study Design
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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


Arms and Interventions
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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.
Other Name: Reproxalap
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.
Other Name: Vehicle of Reproxlap


Outcome Measures
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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.


Eligibility Criteria
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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.
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Aldeyra Therapeutics, Inc.
More Information
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Responsible Party: Aldeyra Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03131154    
Other Study ID Numbers: ADX-102-UV-005
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
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
Pharmaceutical Solutions
Ophthalmic Solutions