Dry EyePhase 3NCT05062330

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

A Phase 3 study testing Reproxalap Ophthalmic Solution (0.25%) in people with Dry Eye, run by Aldeyra Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye
What is being tested?: Reproxalap Ophthalmic Solution (0.25%)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 361 participants
Where: 1 siteUnited States
Study dates: 28 Aug 2021to 4 Mar 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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;

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

Andover Eye Associates (Raynham)
Raynham, Massachusetts, 02767

Other trials in United States

About this study

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

Conditions: Dry Eye
Being tested: Reproxalap Ophthalmic Solution (0.25%), Vehicle Ophthalmic Solution
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05062330
Study group	Role	What they receive
Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days	Experimental	Not described Receives: Drug: Reproxalap Ophthalmic Solution (0.25%)
Vehicle Ophthalmic Solution administered 7 times over two consecutive days	Placebo comparator	Not described Receives: Drug: Vehicle Ophthalmic Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Schirmer Test Mean Change From Baseline
Change from baseline comparison of reproxalap to vehicle for Schirmer test (0 to 35 mm). Higher scores represent greater tear production. The least squares mean (standard error) was derived from a mixed model repeated measures analysis of change from baseline, with baseline as a covariate, and time point and treatment group as factors.
Measured: The efficacy assessment period was before and after the final dose on Day 1 (Dose 4). Baseline was approximately two weeks before dosing at Screening.
Number of Subject Eyes That Are Schirmer Test Responders
Comparison of reproxalap to vehicle for number of subject eyes that are Schirmer test responders (10 millimeters or more increase from baseline). A generalized estimating equation analysis was performed with baseline as a covariate, and time point and treatment group as factors.
Measured: The efficacy assessment period was before and after the final dose on Day 1 (Dose 4). Baseline was approximately two weeks before dosing at Screening.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 20214 Mar 2022

First posted30 Sep 2021
Study start28 Aug 2021
Primary completion4 Mar 2022
Study completion4 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry EyeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 361 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05062330
Sponsor's protocol ID: ADX-102-DED-023
Status last verified: Sep 2021
First submitted: 13 Sep 2021
Last updated: 18 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05062330
Acronym / sponsor ID: ADX-102-DED-023
Conditions: Dry Eye
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 361 participants (actual)
Lead sponsor: Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 28 Aug 2021 (actual)
Primary completion: 4 Mar 2022 (actual)
Study completion: 4 Mar 2022 (actual)
First posted: 30 Sep 2021 (actual)
Results: Posted 18 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days	Experimental	Drug: Reproxalap Ophthalmic Solution (0.25%)
Vehicle Ophthalmic Solution administered 7 times over two consecutive days	Placebo comparator	Drug: Vehicle Ophthalmic Solution

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Reproxalap Ophthalmic Solution (0.25%)Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days	Drug	Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days
Vehicle Ophthalmic SolutionVehicle Ophthalmic Solution administered 7 times over two consecutive days	Drug	Vehicle Ophthalmic Solution administered 7 times over two consecutive days

Primary outcome

Schirmer Test Mean Change From Baseline
Time frame: The efficacy assessment period was before and after the final dose on Day 1 (Dose 4). Baseline was approximately two weeks before dosing at Screening.
Change from baseline comparison of reproxalap to vehicle for Schirmer test (0 to 35 mm). Higher scores represent greater tear production. The least squares mean (standard error) was derived from a mixed model repeated measures analysis of change from baseline, with baseline as a covariate, and time point and treatment group as factors.
Number of Subject Eyes That Are Schirmer Test Responders
Time frame: The efficacy assessment period was before and after the final dose on Day 1 (Dose 4). Baseline was approximately two weeks before dosing at Screening.
Comparison of reproxalap to vehicle for number of subject eyes that are Schirmer test responders (10 millimeters or more increase from baseline). A generalized estimating equation analysis was performed with baseline as a covariate, and time point and treatment group as factors.

Results and safety

Results posted to the registry on 18 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Reproxalap	181	168
Vehicle	180	168

Primary outcome: Schirmer Test Mean Change From Baseline

Time frame: The efficacy assessment period was before and after the final dose on Day 1 (Dose 4). Baseline was approximately two weeks before dosing at Screening.. Least squares mean (Standard Error). Unit: length in millimeters

Measure	Reproxalap n = 181	Vehicle n = 180
Value	1.8 (0.4)	-0.5 (0.4)

Population analysed: Intent-to-treat population with observed data only

Primary outcome: Number of Subject Eyes That Are Schirmer Test Responders

Time frame: The efficacy assessment period was before and after the final dose on Day 1 (Dose 4). Baseline was approximately two weeks before dosing at Screening.. Number. Unit: eyes

Measure	Reproxalap n = 181	Vehicle n = 180
Value	116	54

Reproxalap vs Vehicle: Odds Ratio (OR): 2.63 (95% CI 1.67 to 4.13), p <0.0001, Generalized estimating equation

Population analysed: Intent-to-treat population with observed data only

Adverse events

Time frame: The safety assessment period was two days.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reproxalap	0 of 181 (0%)	145 of 181 (80.1%)	0 of 181
Vehicle	0 of 180 (0%)	6 of 180 (3.3%)	0 of 180

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Reproxalap Ophthalmic Solution (0.25%) in people with Dry Eye, run by Aldeyra Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Schirmer Test Mean Change From Baseline (time frame: The efficacy assessment period was before and after the final dose on Day 1 (Dose 4). Baseline was approximately two weeks before dosing at Screening.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05062330.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.