Dry EyePhase 2NCT05102409
An Exploratory Crossover Clinical Trial to Compare the Activity of Reproxalap and Lifitegrast in a Dry Eye Disease Chamber
A Phase 2 study testing Reproxalap Ophthalmic Solution (0.25%) and Xiidra® (5% lifitegrast ophthalmic solution) in people with Dry Eye, run by Aldeyra Therapeutics, Inc. at 1 site in Canada.
Trial summary
An Exploratory, Single-Center, Double-Masked, Crossover Clinical Trial to Assess Safety and Tolerability of 0.25% Reproxalap Ophthalmic Solution Compared to Xiidra® in Subjects with Dry Eye Disease in a Dry Eye Chamber Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- Reproxalap Ophthalmic Solution (0.25%) and Xiidra® (5% lifitegrast ophthalmic solution)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- 9 Sep 2021to 25 Oct 2021
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eighteen (18) to70 years of age at the time of screening (either gender and any race).
- Ability to provide written informed consent.
- Reported history of dry eye for at least 6 months prior to Visit 1.
Who cannot join
- 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.
- A condition that the investigator feels may put the subject at significant risk may confound the study results or may interfere significantly with the subject's participation in the trial.
- Inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory, Single-Center, Double-Masked, Crossover Clinical Trial to Assess Safety and Tolerability of 0.25% Reproxalap Ophthalmic Solution Compared to Xiidra® in Subjects With Dry Eye Disease in a Dry Eye Chamber
An Exploratory, Single-Center, Double-Masked, Crossover Clinical Trial to Assess Safety and Tolerability of 0.25% Reproxalap Ophthalmic Solution Compared to Xiidra® in Subjects with Dry Eye Disease in a Dry Eye Chamber
- Conditions
- Dry Eye
- Being tested
- Reproxalap Ophthalmic Solution (0.25%), Xiidra® (5% lifitegrast 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%) dosed once
Xiidra® (5% lifitegrast ophthalmic solution)Drug
Xiidra® (5% lifitegrast ophthalmic solution) dosed once
| Study group | Role | What they receive |
|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | Experimental | Single dose Receives: Drug: Reproxalap Ophthalmic Solution (0.25%) |
| Xiidra® (5% lifitegrast ophthalmic solution) | Active comparator | Single dose Receives: Drug: Xiidra® (5% lifitegrast ophthalmic solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Ocular Discomfort
Ocular discomfort (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a mixed model repeated measures (MMRM) analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors.
Measured: The efficacy assessment period was approximately every 5 minutes during a 45-minute dry eye chamber. Baseline was prior to dosing for each treatment period.
Change From Baseline in Ocular Itching
Ocular itching (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a MMRM analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors.
Measured: The efficacy assessment period was approximately every 5 minutes during a 45-minute dry eye chamber. Baseline was prior to dosing for each treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start9 Sep 2021
- Primary completion25 Oct 2021
- Study completion25 Oct 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aldeyra Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102409
- Sponsor's protocol ID
- ADX-102-DED-025
- Status last verified
- Oct 2021
- First submitted
- 18 Oct 2021
- Last updated
- 28 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Single-Center, Double-Masked, Crossover Clinical Trial to Assess Safety and Tolerability of 0.25% Reproxalap Ophthalmic Solution Compared to Xiidra® in Subjects With Dry Eye Disease in a Dry Eye Chamber
- ClinicalTrials.gov ID
- NCT05102409
- Acronym / sponsor ID
- ADX-102-DED-025
- Conditions
- Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Posted 28 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Exploratory, Single-Center, Double-Masked, Crossover Clinical Trial to Assess Safety and Tolerability of 0.25% Reproxalap Ophthalmic Solution Compared to Xiidra® in Subjects with Dry Eye Disease in a Dry Eye Chamber
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | Experimental | Drug: Reproxalap Ophthalmic Solution (0.25%)Single dose |
| Xiidra® (5% lifitegrast ophthalmic solution) | Active comparator | Drug: Xiidra® (5% lifitegrast ophthalmic solution)Single dose |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eighteen (18) to70 years of age at the time of screening (either gender and any race).
- Ability to provide written informed consent.
- Reported history of dry eye for at least 6 months prior to Visit 1.
Key exclusion criteria (4 listed)
- 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.
- A condition that the investigator feels may put the subject at significant risk may confound the study results or may interfere significantly with the subject's participation in the trial.
- Inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits.
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%) dosed once | Drug | Reproxalap Ophthalmic Solution (0.25%) |
| Xiidra® (5% lifitegrast ophthalmic solution)Xiidra® (5% lifitegrast ophthalmic solution) dosed once | Drug | Xiidra® (5% lifitegrast ophthalmic solution) |
Primary outcome
Change From Baseline in Ocular Discomfort
Time frame: The efficacy assessment period was approximately every 5 minutes during a 45-minute dry eye chamber. Baseline was prior to dosing for each treatment period.
Ocular discomfort (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a mixed model repeated measures (MMRM) analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors.
Change From Baseline in Ocular Itching
Time frame: The efficacy assessment period was approximately every 5 minutes during a 45-minute dry eye chamber. Baseline was prior to dosing for each treatment period.
Ocular itching (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a MMRM analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 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 study testing Reproxalap Ophthalmic Solution (0.25%) and Xiidra® (5% lifitegrast ophthalmic solution) in people with Dry Eye, run by Aldeyra Therapeutics, Inc. at 1 site in Canada.
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 4 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 28 Feb 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 Canada. 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 28 Feb 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?
Change From Baseline in Ocular Discomfort (time frame: The efficacy assessment period was approximately every 5 minutes during a 45-minute dry eye chamber. Baseline was prior to dosing for each treatment period.). 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?
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 28 Feb 2025.