The TRANQUILITY 2 Trial: A Phase 3 Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease

Dry Eye Clinical Trial

Official title:

The TRANQUILITY 2 Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 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: NCT05062330
• Other study ID #: ADX-102-DED-023
• Status: Completed
• Phase: Phase 3
• Start date: August 28, 2021
• Est. completion date: March 4, 2022

Study information

• Verified date: September 2021
• Source: Aldeyra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The TRANQUILITY 2 Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 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: 361
• Est. completion date: March 4, 2022
• Est. primary completion date: March 4, 2022
• 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 7 times over two consecutive days
• Vehicle Ophthalmic Solution
Vehicle Ophthalmic Solution administered 7 times over two consecutive days

Locations

Country	Name	City	State
United States	Andover Eye Associates (Raynham)	Raynham	Massachusetts

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	Schirmer's Test overall mean change from baseline	Measured using a sterile Schirmer's Test strip	Day 1
Primary	Schirmer's Test greater than or equal to 10mm (millimeter) responder analysis of change from baseline.	Measured using a sterile Schirmer's Test strip	Day 1
Secondary	Conjunctival redness assessed via digital photography over 90 minutes in the dry eye chamber	Digital photography of conjunctival redness on a 0 to 4 (normal - severe) scale	Day 2