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A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial of Reproxalap to Assess the Safety and Efficacy in Subjects With Dry Eye Disease

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ClinicalTrials.gov Identifier: NCT03916042
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
Aldeyra Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE April 11, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date December 7, 2020
Actual Study Start Date  ICMJE April 23, 2019
Actual Primary Completion Date November 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • Subject-reported ocular dryness score (0 - 100 VAS) [ Time Frame: Efficacy assessment period (Week 2 through Week 12) ]
    The method of assessment is subject-reported ocular dryness score (0 - 100 VAS)
  • Fluorescein nasal region score (Ora Calibra® scale) [ Time Frame: Efficacy assessment period (Week 2 through Week 12) ]
    The method of assessment is Fluorescein nasal region score (Ora Calibra® scale)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • Fluorescein staining [ Time Frame: Efficacy assessment period (Week 2 through Week 12) ]
    The method of assessment for this outcome is the Fluorescein staining Ora Calibra®
  • Unanesthetized Schirmer's Test [ Time Frame: Efficacy assessment period (Week 2 through Week 12) ]
    The method of assessment for this outcome is the Schirmer test strip.
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 A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial of Reproxalap to Assess the Safety and Efficacy in Subjects With Dry Eye Disease
Official Title  ICMJE A Multi-Center, Phase 2, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% Novel Formulation) Compared to Vehicle in Subjects With Dry Eye Disease
Brief Summary A Multi-Center, Phase 2, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% Novel Formulation) Compared to Vehicle in Subjects with Dry Eye Disease
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye
Intervention  ICMJE
  • Drug: Reproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BID
    Reproxalap Opthalmic Solution (0.25% Novel Formulation) administered QID for four weeks, followed by BID administration for eight weeks
  • Drug: Vehicle Ophthalmic Solution (0.25% Novel Formulation) QID to BID
    Vehicle Ophthalmic Solution administered QID for four weeks, followed by BID administration for eight weeks
Study Arms  ICMJE
  • Experimental: Reproxalap (0.25% Novel Formulation) QID to BID
    Intervention: Drug: Reproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BID
  • Placebo Comparator: Vehicle Ophthalmic Solution QID to BID
    Intervention: Drug: Vehicle Ophthalmic Solution (0.25% Novel Formulation) QID to BID
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: August 29, 2019)
206
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2019)
200
Actual Study Completion Date  ICMJE November 22, 2019
Actual Primary Completion Date November 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be at least 18 years of age of either gender and any race;
  • Have a reported history of dry eye for at least 6 months prior to Visit 1;
  • Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1

Exclusion Criteria:

  • Have any clinically significant slit-lamp findings at Visit 1, including active blepharitis; meibomian gland dysfunction (MGD); lid margin inflammation; or active ocular allergies that require therapeutic treatment, or, in the opinion of the investigator may interfere with the assessment of the safety or efficacy of reproxalap or vehicle;
  • Have or be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1;
  • Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
  • Have used any eye drops within 2 hours of Visit 1;
  • Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
  • Have used ophthalmic cyclosporine or lifitigrast 5.0% ophthalmic solution within 90 days of Visit 1;
  • Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
  • Have used temporary or permanent punctal plugs within 30 days prior to Visit 1 or anticipate their use during the study period
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT03916042
Other Study ID Numbers  ICMJE ADX-102-DED-013
Has Data Monitoring Committee No
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 September 2020

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