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Trial record 1 of 1 for:    ADX-102-UV-005
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SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.

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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.

Tracking Information
First Submitted Date  ICMJE April 4, 2017
First Posted Date  ICMJE April 27, 2017
Last Update Posted Date June 26, 2019
Actual Study Start Date  ICMJE April 26, 2017
Actual Primary Completion Date April 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03131154 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non-infectious Anterior Uveitis
Intervention  ICMJE
  • Drug: ADX-102 Ophthalmic Solution (0.5%)
    ADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks.
  • Drug: Vehicle of ADX-102 Ophthalmic Solution
    Vehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks.
Study Arms  ICMJE
  • Experimental: ADX-102 Ophthalmic Solution (0.5%)
    Intervention: Drug: ADX-102 Ophthalmic Solution (0.5%)
  • Placebo Comparator: Vehicle of ADX-102 Ophthalmic Solution
    Intervention: Drug: Vehicle of ADX-102 Ophthalmic Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2019)
125
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2017)
100
Actual Study Completion Date  ICMJE April 26, 2019
Actual Primary Completion Date April 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03131154
Other Study ID Numbers  ICMJE ADX-102-UV-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aldeyra Therapeutics, Inc.
Study Sponsor  ICMJE Aldeyra Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aldeyra Therapeutics, Inc.
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP