Dry Eye SyndromesPhase 2NCT03162783

A Randomized, Double Masked, Clinical Study of Subjects With Dry Eye Syndrome

A Phase 2 study testing ADX-102 Ophthalmic Solution (0.5%), ADX-102 Ophthalmic Solution (0.1%) and ADX-102 Ophthalmic Lipid Solution (0.5%) in people with 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 objective of this study is to evaluate the safety, tolerability, and pharmacodynamic activity of ADX-102 Ophthalmic Solutions and ADX-102 Ophthalmic Lipid Solution in subjects with dry eye syndrome. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndromes
What is being tested?: ADX-102 Ophthalmic Solution (0.5%), ADX-102 Ophthalmic Solution (0.1%) and ADX-102 Ophthalmic Lipid Solution (0.5%)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 15 May 2017to 6 Jul 2017
Phase: Phase 2
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

Be at least 18 years of age of either gender and any race;
Have a reported history of dry eye for at least 6 months prior to Visit 1;
Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;

Who cannot join

Have any 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;
Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
Have used cyclosporine 0.05% or lifitegrast 5.0% ophthalmic solution within 45 days of Visit 1;
Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within the last 6 months;
Be using or anticipate using 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
Andover, Massachusetts, 01810

Other trials in United States

About this study

Official title: A Single-Center, Phase 2a, Randomized, Double Masked, Clinical Study to Assess the Safety, Tolerability, and Pharmacodynamic Activity of ADX-102 Ophthalmic Solution in Subjects With Dry Eye Syndrome

Conditions: Dry Eye Syndromes
Being tested: ADX-102 Ophthalmic Solution (0.5%), ADX-102 Ophthalmic Solution (0.1%), ADX-102 Ophthalmic Lipid Solution (0.5%)
Keywords: Aldeyra
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.

ADX-102 Ophthalmic Solution (0.5%)Drug
ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks.
ADX-102 Ophthalmic Solution (0.1%)Drug
ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks.
ADX-102 Ophthalmic Lipid Solution (0.5%)Drug
ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks.

Study groups in NCT03162783
Study group	Role	What they receive
ADX-102 Ophthalmic Solution (0.5%)	Experimental	Not described Receives: Drug: ADX-102 Ophthalmic Solution (0.5%)
ADX-102 Ophthalmic Solution (0.1%)	Experimental	Not described Receives: Drug: ADX-102 Ophthalmic Solution (0.1%)
ADX-102 Ophthalmic Lipid Solution (0.5%)	Experimental	Not described Receives: Drug: ADX-102 Ophthalmic Lipid Solution (0.5%)

What is being measured

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

Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.
Change from baseline of ADX-102 on ocular discomfort in subjects with dry eye disease using the Ora Calibra® Ocular Discomfort Scale (0 = least, 4 = most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Measured: Efficacy assessment period (Day 1 through Day 29), Day 29 reported.

Timeline

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

15 May 20176 Jul 2017

First posted22 May 2017
Study start15 May 2017
Primary completion6 Jul 2017
Study completion6 Jul 2017

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dry Eye SyndromesStudies 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
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03162783
Sponsor's protocol ID: ADX-102-DES-007
Status last verified: Jun 2018
First submitted: 19 May 2017
Last updated: 16 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Clark D, Sheppard J, Brady TC. A Randomized Double-Masked Phase 2a Trial to Evaluate Activity and Safety of Topical Ocular Reproxalap, a Novel RASP Inhibitor, in Dry Eye Disease. J Ocul Pharmacol Ther. 2021 May;37(4):193-199. doi: 10.1089/jop.2020.0087. Epub 2021 Jan 15.
PubMed 33450164

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 Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Phase 2a, Randomized, Double Masked, Clinical Study to Assess the Safety, Tolerability, and Pharmacodynamic Activity of ADX-102 Ophthalmic Solution in Subjects With Dry Eye Syndrome
ClinicalTrials.gov ID: NCT03162783
Acronym / sponsor ID: ADX-102-DES-007
Conditions: Dry Eye Syndromes
Keywords: Aldeyra
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 15 May 2017 (actual)
Primary completion: 6 Jul 2017 (actual)
Study completion: 6 Jul 2017 (actual)
First posted: 22 May 2017 (actual)
Results: Posted 16 Jan 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
ADX-102 Ophthalmic Solution (0.5%)	Experimental	Drug: ADX-102 Ophthalmic Solution (0.5%)
ADX-102 Ophthalmic Solution (0.1%)	Experimental	Drug: ADX-102 Ophthalmic Solution (0.1%)
ADX-102 Ophthalmic Lipid Solution (0.5%)	Experimental	Drug: ADX-102 Ophthalmic Lipid Solution (0.5%)

Who may qualify

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

Key inclusion criteria (3 listed)

Be at least 18 years of age of either gender and any race;
Have a reported history of dry eye for at least 6 months prior to Visit 1;
Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;

Key exclusion criteria (7 listed)

Have any 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;
Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
Have used cyclosporine 0.05% or lifitegrast 5.0% ophthalmic solution within 45 days of Visit 1;

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
ADX-102 Ophthalmic Solution (0.5%)ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks.	Drug	ADX-102 Ophthalmic Solution (0.5%)
ADX-102 Ophthalmic Solution (0.1%)ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks.	Drug	ADX-102 Ophthalmic Solution (0.1%)
ADX-102 Ophthalmic Lipid Solution (0.5%)ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks.	Drug	ADX-102 Ophthalmic Lipid Solution (0.5%)

Primary outcome

Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.
Time frame: Efficacy assessment period (Day 1 through Day 29), Day 29 reported.
Change from baseline of ADX-102 on ocular discomfort in subjects with dry eye disease using the Ora Calibra® Ocular Discomfort Scale (0 = least, 4 = most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.

Results and safety

Results posted to the registry on 16 Jan 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
ADX-102 Ophthalmic Solution (0.5%)	17	12
ADX-102 Ophthalmic Solution (0.1%)	17	16
ADX-102 Ophthalmic Lipid Solution (0.5%)	17	11

Primary outcome: Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.

Time frame: Efficacy assessment period (Day 1 through Day 29), Day 29 reported.. Mean (Standard Deviation). Unit: units on a scale

Measure	ADX-102 Ophthalmic Solution (0.1%) n = 16	ADX-102 Ophthalmic Solution (0.5%) n = 12	ADX-102 Ophthalmic Lipid Solution (0.5%) n = 11
Value	-0.81 (0.98)	-0.75 (0.75)	-0.82 (1.33)

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

Adverse events

Time frame: The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ADX-102 Ophthalmic Solution (0.5%)	0 of 17 (0%)	17 of 17 (100%)	0 of 17
ADX-102 Ophthalmic Solution (0.1%)	0 of 17 (0%)	8 of 17 (47.1%)	0 of 17
ADX-102 Ophthalmic Lipid Solution (0.5%)	0 of 17 (0%)	17 of 17 (100%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33450164Clark D, Sheppard J, Brady TC. A Randomized Double-Masked Phase 2a Trial to Evaluate Activity and Safety of Topical Ocular Reproxalap, a Novel RASP Inhibitor, in Dry Eye Disease. J Ocul Pharmacol Ther. 2021 May;37(4):193-199. doi: 10.1089/jop.2020.0087. Epub 2021 Jan 15.
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?

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 7 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 16 Jan 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 16 Jan 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?

Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale. (time frame: Efficacy assessment period (Day 1 through Day 29), Day 29 reported.). 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 NCT03162783, which also lists 1 linked publication.

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 16 Jan 2025.