- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04674358
The TRANQUILITY Trial: Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease
March 28, 2022 updated by: Aldeyra Therapeutics, Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
331
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Memphis, Tennessee, United States, 38103
- University Clinical Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Reproxalap Ophthalmic Solution (0.25%) administered QID over two consecutive days.
|
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.
|
Vehicle Ophthalmic Solution administered over two consecutive days (Day one pre-dry eye chamber and Day two dry eye chamber assessment).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Day 2.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in tear RASP (reactive aldehyde species) levels.
Time Frame: Day 1 and 2.
|
Tear levels of RASP.
|
Day 1 and 2.
|
Schirmer's Test
Time Frame: Day 1.
|
Measured using a sterile Schirmer's Test Strip.
|
Day 1.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 21, 2020
Primary Completion (Actual)
September 12, 2021
Study Completion (Actual)
September 12, 2021
Study Registration Dates
First Submitted
December 14, 2020
First Submitted That Met QC Criteria
December 17, 2020
First Posted (Actual)
December 19, 2020
Study Record Updates
Last Update Posted (Actual)
March 29, 2022
Last Update Submitted That Met QC Criteria
March 28, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADX-102-DED-019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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