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The TRANQUILITY 2 Trial: A Phase 3 Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Reproxalap Ophthalmic Solution (0.25%)
Vehicle Ophthalmic Solution
Sponsored by
Aldeyra Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
  • Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
  • Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial;
  • Eye drop use within 2 hours of Visit 1;
  • Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
  • Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution use within 90 days of Visit 1;
  • Be receiving systemic corticosteroid therapy (not including inhaled corticosteroids) within 14 days of Visit 1 or anticipate such therapy throughout the study period;
  • Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
  • Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1

Sites / Locations

  • Andover Eye Associates (Raynham)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days

Vehicle Ophthalmic Solution administered 7 times over two consecutive days

Arm Description

Outcomes

Primary Outcome Measures

Schirmer's Test overall mean change from baseline
Measured using a sterile Schirmer's Test strip
Schirmer's Test greater than or equal to 10mm (millimeter) responder analysis of change from baseline.
Measured using a sterile Schirmer's Test strip

Secondary Outcome Measures

Conjunctival redness assessed via digital photography over 90 minutes in the dry eye chamber
Digital photography of conjunctival redness on a 0 to 4 (normal - severe) scale

Full Information

First Posted
September 13, 2021
Last Updated
February 15, 2023
Sponsor
Aldeyra Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05062330
Brief Title
The TRANQUILITY 2 Trial: A Phase 3 Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease
Official Title
The TRANQUILITY 2 Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 28, 2021 (Actual)
Primary Completion Date
March 4, 2022 (Actual)
Study Completion Date
March 4, 2022 (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
The TRANQUILITY 2 Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution 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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
361 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days
Arm Type
Experimental
Arm Title
Vehicle Ophthalmic Solution administered 7 times over two consecutive days
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Reproxalap Ophthalmic Solution (0.25%)
Intervention Description
Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days
Intervention Type
Drug
Intervention Name(s)
Vehicle Ophthalmic Solution
Intervention Description
Vehicle Ophthalmic Solution administered 7 times over two consecutive days
Primary Outcome Measure Information:
Title
Schirmer's Test overall mean change from baseline
Description
Measured using a sterile Schirmer's Test strip
Time Frame
Day 1
Title
Schirmer's Test greater than or equal to 10mm (millimeter) responder analysis of change from baseline.
Description
Measured using a sterile Schirmer's Test strip
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Conjunctival redness assessed via digital photography over 90 minutes in the dry eye chamber
Description
Digital photography of conjunctival redness on a 0 to 4 (normal - severe) scale
Time Frame
Day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age (either gender and any race); Reported history of dry eye for at least 6 months prior to Visit 1; Reported history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1 Exclusion Criteria: Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1; Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial; Eye drop use within 2 hours of Visit 1; Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months; Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution use within 90 days of Visit 1; Be receiving systemic corticosteroid therapy (not including inhaled corticosteroids) within 14 days of Visit 1 or anticipate such therapy throughout the study period; Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1; Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1
Facility Information:
Facility Name
Andover Eye Associates (Raynham)
City
Raynham
State/Province
Massachusetts
ZIP/Postal Code
02767
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The TRANQUILITY 2 Trial: A Phase 3 Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease

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