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

NCT04674358 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ADX-102-DED-019
• Study Type: interventional
• Target: 329
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye; Dry Eye Syndromes

Keywords

reproxalap; ADX-102; Tranquility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Schirmer Test Change From Baseline After the First Dose on Day 1

  The efficacy assessment period was before and after the final dose on Day 1; baseline was Pre-Dose #1 at Day 1.

Study Arms (2)

Reproxalap Ophthalmic Solution (0.25%) administered QID over two consecutive days.

EXPERIMENTAL

Drug: Reproxalap Ophthalmic Solution (0.25%)

Vehicle Ophthalmic Solution administered over two consecutive days.

PLACEBO COMPARATOR

Drug: Vehicle Opthalmic Solution

Interventions

Reproxalap Ophthalmic Solution (0.25%) DRUG

Reproxalap Ophthalmic Solution (0.25%) administered over two consecutive days (Day one pre-dry eye chamber and Day two dry eye chamber assessment).

Reproxalap Ophthalmic Solution (0.25%) administered QID over two consecutive days.

Vehicle Opthalmic Solution DRUG

Vehicle Ophthalmic Solution administered over two consecutive days (Day one pre-dry eye chamber and Day two dry eye chamber assessment).

Vehicle Ophthalmic Solution administered over two consecutive days.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (1)

University Clinical Health

Memphis, Tennessee, 38103, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Sr. Director, Clinical Operations
• Organization: Aldeyra Therapeutics, Inc.

bcavanagh@aldeyra.com

781-257-3063

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: November 21, 2020
• Primary Completion: September 12, 2021
• Study Completion: September 12, 2021
• Last Updated: March 19, 2025
• Results First Posted: March 19, 2025

Record last verified: 2023-02

Locations

US (1)