The TRANQUILITY Trial: Clinical Trial to Assess the Efficacy and Safety 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

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: Dry Eye; Dry Eye Syndromes
• Intervention / Treatment: Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Vehicle Opthalmic Solution

• Study Type: Interventional
• Enrollment (Actual): 329
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • University Clinical Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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).

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	Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = normal, 4 = prominent), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline, site, treatment group, and nominal time point as fixed effects.	The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schirmer Test Change From Baseline After the First Dose on Day 1	Change from baseline comparison of reproxalap to vehicle for Schirmer test on a millimeter line (0 = none, 35 = maximum), where a shorter length indicates a worse outcome. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline and treatment group as fixed effects.	The efficacy assessment period was before and after the final dose on Day 1; baseline was Pre-Dose #1 at Day 1.

Collaborators and Investigators

• Sponsor: Aldeyra Therapeutics, Inc.

Study record dates

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 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: reproxalap; ADX-102; Tranquility
• Additional Relevant MeSH Terms: Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• 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