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

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04674358
• Other study ID #: ADX-102-DED-019
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 21, 2020
• Est. completion date: September 12, 2021

Study information

• Verified date: March 2022
• Source: Aldeyra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: September 12, 2021
• Est. primary completion date: September 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
United States	University Clinical Health	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Aldeyra Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conjunctival redness assessed over 90 minutes in the dry eye chamber.	Ora Calibra® Conjunctival Redness Scale for Dry Eye (0 = Normal, 4 = Severe).	Day 2.
Secondary	Change in tear RASP (reactive aldehyde species) levels.	Tear levels of RASP.	Day 1 and 2.
Secondary	Schirmer's Test	Measured using a sterile Schirmer's Test Strip.	Day 1.