Phase 3
N=327
The TRANQUILITY Trial: Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease
Dry Eye · Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT04674358 ↗Enrolled (actual)
327
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Conjunctival Redness Assessed Over 90 Minutes in the Dry Eye Chamber — 0.185; 0.156 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Reproxalap Ophthalmic Solution (0.25%) (Drug); Vehicle Opthalmic Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aldeyra Therapeutics, Inc.
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Conjunctival Redness Assessed Over 90 Minutes in the Dry Eye Chamber |
0.185; 0.156 | — |
| SECONDARY Schirmer Test Change From Baseline After the First Dose on Day 1 |
5.9; 3.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04674358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.