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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04674358
Recruitment Status : Recruiting
First Posted : December 19, 2020
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Aldeyra Therapeutics, Inc.

Study Description
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Brief Summary:
The TRANQUILITY Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2/3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease.

Condition or disease Intervention/treatment Phase
Dry Eye Dry Eye Syndromes Drug: Reproxalap Ophthalmic Solution (0.25%) Drug: Vehicle Opthalmic Solution Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The TRANQUILITY Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2/3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
Actual Study Start Date : November 21, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Reproxalap Ophthalmic Solution (0.25%) administered QID over two consecutive days. Drug: Reproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.25%) administered over two consecutive days (Day one pre-dry eye chamber and Day two dry eye chamber assessment).
Placebo Comparator: Vehicle Ophthalmic Solution administered over two consecutive days. Drug: Vehicle Opthalmic Solution
Vehicle Ophthalmic Solution administered over two consecutive days (Day one pre-dry eye chamber and Day two dry eye chamber assessment).


Outcome Measures
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Primary Outcome Measures :
  1. Conjunctival redness assessed over 90 minutes in the dry eye chamber. [ Time Frame: Day 2. ]
    Ora Calibra® Conjunctival Redness Scale for Dry Eye (0 = Normal, 4 = Severe).


Secondary Outcome Measures :
  1. Change in tear RASP (reactive aldehyde species) levels. [ Time Frame: Day 1 and 2. ]
    Tear levels of RASP.

  2. Schirmer's Test [ Time Frame: Day 1. ]
    Measured using a sterile Schirmer's Test Strip.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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): NCT04674358


Contacts
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Contact: Bill Cavanagh 781-257-3063 bcavanagh@aldeyra.com
Contact: James Gow, MD

Locations
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United States, Tennessee
University Clinical Health Recruiting
Memphis, Tennessee, United States, 38103
Contact: Brian M. Jerkins, MD    901-448-6650      
Sponsors and Collaborators
Aldeyra Therapeutics, Inc.
More Information
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Responsible Party: Aldeyra Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04674358    
Other Study ID Numbers: ADX-102-DED-019
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021

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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
ADX-102
Tranquility
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
 Conjunctival Diseases
Keratitis
Corneal Diseases
Pharmaceutical Solutions
Ophthalmic Solutions