Dry EyePhase 2/3NCT04674358

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

A Phase 2/3 study testing Reproxalap Ophthalmic Solution (0.25%) in people with Dry Eye and Dry Eye Syndromes, 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 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye, Dry Eye Syndromes
What is being tested?: Reproxalap Ophthalmic Solution (0.25%)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 329 participants
Where: 1 siteUnited States
Study dates: 21 Nov 2020to 12 Sep 2021
Phase: Phase 2/3
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

University Clinical Health
Memphis, Tennessee, 38103

Other trials in United States

About this study

Official title: 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

Conditions: Dry Eye, Dry Eye Syndromes
Being tested: Reproxalap Ophthalmic Solution (0.25%), Vehicle Opthalmic Solution
Keywords: reproxalap, ADX-102, Tranquility
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 over two consecutive days (Day one pre-dry eye chamber and Day two dry eye chamber assessment).
Vehicle Opthalmic SolutionDrug
Vehicle Ophthalmic Solution administered over two consecutive days (Day one pre-dry eye chamber and Day two dry eye chamber assessment).

Study groups in NCT04674358
Study group	Role	What they receive
Reproxalap Ophthalmic Solution (0.25%) administered QID over two consecutive days.	Experimental	Not described Receives: Drug: Reproxalap Ophthalmic Solution (0.25%)
Vehicle Ophthalmic Solution administered over two consecutive days.	Placebo comparator	Not described Receives: Drug: Vehicle Opthalmic Solution

What is being measured

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

Conjunctival Redness Assessed Over 90 Minutes in the Dry Eye Chamber
Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = normal, 4 = prominent), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline, site, treatment group, and nominal time point as fixed effects.
Measured: The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1.

Secondary outcomes (1)

Schirmer Test Change From Baseline After the First Dose on Day 1
Change from baseline comparison of reproxalap to vehicle for Schirmer test on a millimeter line (0 = none, 35 = maximum), where a shorter length indicates a worse outcome. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline and treatment group as fixed effects.
Measured: The efficacy assessment period was before and after the final dose on Day 1; baseline was Pre-Dose #1 at Day 1.

Timeline

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

21 Nov 202012 Sep 2021

First posted19 Dec 2020
Study start21 Nov 2020
Primary completion12 Sep 2021
Study completion12 Sep 2021

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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 329 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04674358
Sponsor's protocol ID: ADX-102-DED-019
Status last verified: Feb 2023
First submitted: 14 Dec 2020
Last updated: 19 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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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All Dry Eye trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04674358
Acronym / sponsor ID: ADX-102-DED-019
Conditions: Dry Eye, Dry Eye Syndromes
Keywords: reproxalap, ADX-102, Tranquility
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 329 participants (actual)
Lead sponsor: Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 21 Nov 2020 (actual)
Primary completion: 12 Sep 2021 (actual)
Study completion: 12 Sep 2021 (actual)
First posted: 19 Dec 2020 (actual)
Results: Posted 19 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 QID over two consecutive days.	Experimental	Drug: Reproxalap Ophthalmic Solution (0.25%)
Vehicle Ophthalmic Solution administered over two consecutive days.	Placebo comparator	Drug: Vehicle Opthalmic 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 over two consecutive days (Day one pre-dry eye chamber and Day two dry eye chamber assessment).	Drug	Reproxalap Ophthalmic Solution (0.25%) administered QID over two consecutive days.
Vehicle Opthalmic SolutionVehicle Ophthalmic Solution administered over two consecutive days (Day one pre-dry eye chamber and Day two dry eye chamber assessment).	Drug	Vehicle Ophthalmic Solution administered over two consecutive days.

Primary outcome

Conjunctival Redness Assessed Over 90 Minutes in the Dry Eye Chamber
Time frame: The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1.
Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = normal, 4 = prominent), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline, site, treatment group, and nominal time point as fixed effects.

1 secondary outcome

Schirmer Test Change From Baseline After the First Dose on Day 1
Time frame: The efficacy assessment period was before and after the final dose on Day 1; baseline was Pre-Dose #1 at Day 1.

Results and safety

Results posted to the registry on 19 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 Ophthalmic Solution (0.25%)	164	162
Vehicle	163	160

Primary outcome: Conjunctival Redness Assessed Over 90 Minutes in the Dry Eye Chamber

Time frame: The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1.. Least squares mean (Standard Error). Unit: units on a scale

Measure	Reproxalap Ophthalmic Solution (0.25%) n = 153	Vehicle n = 153
Value	0.185 (0.0233)	0.156 (0.0229)

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The period of time over which adverse events were collected for each subject in the clinical trial was approximately one week.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reproxalap Ophthalmic Solution (0.25%)	0 of 164 (0%)	118 of 164 (72%)	0 of 164
Vehicle	0 of 163 (0%)	2 of 163 (1.2%)	0 of 163

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 2/3 study testing Reproxalap Ophthalmic Solution (0.25%) in people with Dry Eye and Dry Eye Syndromes, 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 19 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 19 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?

Conjunctival Redness Assessed Over 90 Minutes in the Dry Eye Chamber (time frame: The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1.). 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 NCT04674358.

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 19 Mar 2025.