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

Phase 2

Completed

• Conditions: Dry Eye; Dry Eye Syndromes
• Interventions: Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Vehicle Opthalmic Solution

• Registration Number: NCT04674358
• Lead Sponsor: Aldeyra Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-21
• Study First Submitted: 2020-12-14
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-19
• Primary Completion: 2021-09-12
• Study Completion: 2021-09-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 331

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reproxalap Ophthalmic Solution (0.25%) administered QID over two consecutive days.	Reproxalap Ophthalmic Solution (0.25%)	-
Vehicle Ophthalmic Solution administered over two consecutive days.	Vehicle Opthalmic Solution	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

University Clinical Health; 🇺🇸 Memphis, Tennessee, United States