Conjunctivitis, AllergicPhase 1/2NCT03709121
A Methodology Development Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber
A Phase 1/2 study testing Reproxalap Ophthalmic Solution (0.25%) and Reproxalap Ophthalmic Solution (0.5%) in people with Conjunctivitis, Allergic, run by Aldeyra Therapeutics, Inc. at 1 site in Canada.
Trial summary
An Exploratory Clinical Trial Evaluating Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conjunctivitis, Allergic
- What is being tested?
- Reproxalap Ophthalmic Solution (0.25%) and Reproxalap Ophthalmic Solution (0.5%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 2 Oct 2018to 20 Mar 2019
- Phase
- Phase 1/2
- 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 at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on principal investigator's judgement
- have a positive skin prick test to ragweed pollen within the past year of screening
Who cannot join
- known contraindication or hypersensitivities to any components of the investigational product medication or components
- history of uveitis, blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
- presence of any ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to screening
- presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial;
- presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial
- diagnosis of moderate-to-severe pinguecula or pterygium (particularly if it results in chronic erythema), Stevens-Johnson Syndrome, ocular cicatricial pemphigoid, mucous membrane pemphigoid, significant conjunctival scarring, chemical burn, herpetic or neurotrophic keratitis, Cryopyrin Associated Periodic Syndrome (CAPS), or keratoconus
- woman of childbearing potential who is pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Clinical Trial Evaluating Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)
An Exploratory Clinical Trial Evaluating Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)
- Conditions
- Conjunctivitis, Allergic
- Being tested
- Reproxalap Ophthalmic Solution (0.25%), Reproxalap Ophthalmic Solution (0.5%), Vehicle Ophthalmic Solution
- Keywords
- reproxalap, ADX-102, allergic conjunctivitis
- Medical subject headings
- Conjunctivitis, Allergic
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 twice.
Reproxalap Ophthalmic Solution (0.5%)Drug
Reproxalap Ophthalmic Solution (0.5%) dosed twice.
Vehicle Ophthalmic SolutionDrug
Vehicle Ophthalmic Solution dosed twice.
| Study group | Role | What they receive |
|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | Experimental | Not described Receives: Drug: Reproxalap Ophthalmic Solution (0.25%) |
| Reproxalap Ophthalmic Solution (0.5%) | Experimental | Not described Receives: Drug: Reproxalap Ophthalmic Solution (0.5%) |
| Vehicle Ophthalmic Solution | 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.
Subject-Reported Ocular Itching Score
Change from baseline comparison of reproxalap to vehicle for subject-reported ocular itching score from 0 to 212 minutes in the allergen chamber using a 0 -100 millimeter visual analogue scale (0 = none, 100 = severe) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.
Measured: Efficacy was assessed from 0 to 212 minutes in the allergen chamber.
Secondary outcomes (2)
Subject-Reported Ocular Tearing Score
Change from baseline comparison of reproxalap to vehicle for subject-reported ocular tearing score from 0 to 212 minutes in the allergen chamber using a 4-point scale (0 = none, 3 = severe) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.
Measured: Efficacy was assessed from 0 to 212 minutes in the allergen chamber.
Investigator-Assessed Conjunctival Redness Score
Change from baseline comparison of reproxalap to vehicle for investigator-assessed conjunctival redness from 0 to 210 minutes in the allergen chamber using a 9-point scale with half unit increments (0 = normal, 4 = prominent) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.
Measured: Efficacy was assessed from 0 to 210 minutes in the allergen chamber.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start2 Oct 2018
- Primary completion20 Mar 2019
- Study completion20 Mar 2019
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 Conjunctivitis, AllergicStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 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
- NCT03709121
- Sponsor's protocol ID
- ADX-102-AC-011
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2018
- Last updated
- 24 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Trial Evaluating Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)
- ClinicalTrials.gov ID
- NCT03709121
- Acronym / sponsor ID
- ADX-102-AC-011
- Conditions
- Conjunctivitis, Allergic
- Keywords
- reproxalap, ADX-102, allergic conjunctivitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Posted 24 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 Clinical Trial Evaluating Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | Experimental | Drug: Reproxalap Ophthalmic Solution (0.25%) |
| Reproxalap Ophthalmic Solution (0.5%) | Experimental | Drug: Reproxalap Ophthalmic Solution (0.5%) |
| Vehicle Ophthalmic Solution | 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)
- be at least 18 years of age of either gender and any race
- have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on principal investigator's judgement
- have a positive skin prick test to ragweed pollen within the past year of screening
Key exclusion criteria (7 listed)
- known contraindication or hypersensitivities to any components of the investigational product medication or components
- history of uveitis, blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
- presence of any ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to screening
- presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial;
- presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial
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 twice. | Drug | Reproxalap Ophthalmic Solution (0.25%) |
| Reproxalap Ophthalmic Solution (0.5%)Reproxalap Ophthalmic Solution (0.5%) dosed twice. | Drug | Reproxalap Ophthalmic Solution (0.5%) |
| Vehicle Ophthalmic SolutionVehicle Ophthalmic Solution dosed twice. | Drug | Vehicle Ophthalmic Solution |
Primary outcome
Subject-Reported Ocular Itching Score
Time frame: Efficacy was assessed from 0 to 212 minutes in the allergen chamber.
Change from baseline comparison of reproxalap to vehicle for subject-reported ocular itching score from 0 to 212 minutes in the allergen chamber using a 0 -100 millimeter visual analogue scale (0 = none, 100 = severe) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.
2 secondary outcomes
Subject-Reported Ocular Tearing Score
Time frame: Efficacy was assessed from 0 to 212 minutes in the allergen chamber.
Investigator-Assessed Conjunctival Redness Score
Time frame: Efficacy was assessed from 0 to 210 minutes in the allergen chamber.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 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 1/2 study testing Reproxalap Ophthalmic Solution (0.25%) and Reproxalap Ophthalmic Solution (0.5%) in people with Conjunctivitis, Allergic, 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 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 24 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 24 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?
Subject-Reported Ocular Itching Score (time frame: Efficacy was assessed from 0 to 212 minutes in the allergen chamber.). 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 24 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.