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

Phase 3

Completed

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

• Registration Number: NCT05062330
• Lead Sponsor: Aldeyra Therapeutics, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-28
• Status Verified: 2021-09
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-09-30
• Primary Completion: 2022-03-04
• Study Completion: 2022-03-04
• Disposition First Submitted: 2023-02-10
• Last Update Submitted: 2023-02-15
• Disposition First Posted: 2023-02-17
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 361

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 7 times over two consecutive days	Reproxalap Ophthalmic Solution (0.25%)	-
Vehicle Ophthalmic Solution administered 7 times over two consecutive days	Vehicle Ophthalmic Solution	-

Primary Outcome Measures

Name	Time	Method
Schirmer's Test overall mean change from baseline	Day 1	Measured using a sterile Schirmer's Test strip
Schirmer's Test greater than or equal to 10mm (millimeter) responder analysis of change from baseline.	Day 1	Measured using a sterile Schirmer's Test strip

Secondary Outcome Measures

Name	Time	Method
Conjunctival redness assessed via digital photography over 90 minutes in the dry eye chamber	Day 2	Digital photography of conjunctival redness on a 0 to 4 (normal - severe) scale

Trial Locations

Locations (1)

Andover Eye Associates (Raynham); 🇺🇸 Raynham, Massachusetts, United States