The TRANQUILITY 2 Trial: A Phase 3 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: NCT05062330
• Collaborator: (none)
• Enrollment: 361
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.2
• Patients Per Site Per Month: 58.4

Study Details

Study Description

Brief Summary

The TRANQUILITY 2 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	Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Vehicle Ophthalmic Solution	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 361 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 28, 2021
• Actual Primary Completion Date: Mar 4, 2022
• Actual Study Completion Date: Mar 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days	Drug: Reproxalap Ophthalmic Solution (0.25%); Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days
Placebo Comparator: Vehicle Ophthalmic Solution administered 7 times over two consecutive days	Drug: Vehicle Ophthalmic Solution; Vehicle Ophthalmic Solution administered 7 times over two consecutive days

Outcome Measures

Primary Outcome Measures

1. Schirmer's Test overall mean change from baseline [Day 1]

   Measured using a sterile Schirmer's Test strip

2. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Andover Eye Associates (Raynham)	Raynham	Massachusetts	United States	02767

Sponsors and Collaborators

• Aldeyra Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aldeyra Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT05062330
• Other Study ID Numbers: ADX-102-DED-023
• First Posted: Sep 30, 2021
• Last Update Posted: Aug 3, 2022
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

No Results Posted as of Aug 3, 2022