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

Sponsor

Aldeyra Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04674358

Collaborator

(none)

331

Enrollment

Location

Arms

9.7

Actual Duration (Months)

34.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Dry Eye Syndromes	Drug: Reproxalap Ophthalmic Solution (0.25%) Drug: Vehicle Opthalmic Solution	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

331 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Actual Study Start Date :

Nov 21, 2020

Actual Primary Completion Date :

Sep 12, 2021

Actual Study Completion Date :

Sep 12, 2021

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Conjunctival redness assessed over 90 minutes in the dry eye chamber. [Day 2.]
Ora Calibra® Conjunctival Redness Scale for Dry Eye (0 = Normal, 4 = Severe).

Secondary Outcome Measures

Change in tear RASP (reactive aldehyde species) levels. [Day 1 and 2.]
Tear levels of RASP.
Schirmer's Test [Day 1.]
Measured using a sterile Schirmer's Test Strip.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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