Back to resultsA 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
Primary Purpose
Dry Eye
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Reproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BID
Vehicle Ophthalmic Solution (0.25% Novel Formulation) QID to BID
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
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
Sites / Locations
- Andover Eye Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Reproxalap (0.25% Novel Formulation) QID to BID
Vehicle Ophthalmic Solution QID to BID
Arm Description
Outcomes
Primary Outcome Measures
Subject-reported ocular dryness score (0 - 100 VAS)
The method of assessment is subject-reported ocular dryness score (0 - 100 VAS)
Fluorescein nasal region score (Ora Calibra® scale)
The method of assessment is Fluorescein nasal region score (Ora Calibra® scale)
Secondary Outcome Measures
Fluorescein staining
The method of assessment for this outcome is the Fluorescein staining Ora Calibra®
Unanesthetized Schirmer's Test
The method of assessment for this outcome is the Schirmer test strip.
Full Information
NCT ID
NCT03916042
First Posted
April 11, 2019
Last Updated
December 2, 2020
Sponsor
Aldeyra Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03916042
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 23, 2019 (Actual)
Primary Completion Date
November 22, 2019 (Actual)
Study Completion Date
November 22, 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
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
206 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reproxalap (0.25% Novel Formulation) QID to BID
Arm Type
Experimental
Arm Title
Vehicle Ophthalmic Solution QID to BID
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Reproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BID
Intervention Description
Reproxalap Opthalmic Solution (0.25% Novel Formulation) administered QID for four weeks, followed by BID administration for eight weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle Ophthalmic Solution (0.25% Novel Formulation) QID to BID
Intervention Description
Vehicle Ophthalmic Solution administered QID for four weeks, followed by BID administration for eight weeks
Primary Outcome Measure Information:
Title
Subject-reported ocular dryness score (0 - 100 VAS)
Description
The method of assessment is subject-reported ocular dryness score (0 - 100 VAS)
Time Frame
Efficacy assessment period (Week 2 through Week 12)
Title
Fluorescein nasal region score (Ora Calibra® scale)
Description
The method of assessment is Fluorescein nasal region score (Ora Calibra® scale)
Time Frame
Efficacy assessment period (Week 2 through Week 12)
Secondary Outcome Measure Information:
Title
Fluorescein staining
Description
The method of assessment for this outcome is the Fluorescein staining Ora Calibra®
Time Frame
Efficacy assessment period (Week 2 through Week 12)
Title
Unanesthetized Schirmer's Test
Description
The method of assessment for this outcome is the Schirmer test strip.
Time Frame
Efficacy assessment period (Week 2 through Week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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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