Allergic ConjunctivitisPhase 3NCT03494504
ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis
A Phase 3 study testing Reproxalap Ophthalmic Solution (0.25%) and Reproxalap Ophthalmic Solution (0.5%) in people with Allergic Conjunctivitis, run by Aldeyra Therapeutics, Inc. at 7 sites in United States.
Trial summary
A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute Allergic Conjunctivitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- 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
- 318 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Mar 2018to 5 Nov 2018
- 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
- be at least 18 years of age of either gender and any race
- have a positive history of ocular allergies and a positive skin test reaction to a seasonal allergen (grasses, ragweed, and/or trees) as confirmed by an allergic skin test at the Screening Visit or within the past 24 months;
- have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart
Who cannot join
- have known contraindications or sensitivities to the use of the investigational product or any of its components
- have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye)
- have had ocular surgical intervention within three (3) months prior to Visit 1 or during the trial and/or a history of refractive surgery six (6) months prior to Visit 1 or have ocular or systemic surgery planned during the study or within 30 days after
- have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
- have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit
- be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the trial duration, or has a positive urine pregnancy test at Visit 1
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Andover Eye Associates
Andover, Massachusetts, 01810
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, 21078
Cornea Consultants of Arizon
Phoenix, Arizona, 85032
Eye Site Sacramento
Sacramento, California, 95819
Eye Clinics of South Texas
San Antonio, Texas, 78209
R & R Research, LLC
San Antonio, Texas, 78229
East West Eye Institute
Torrance, California, 90505
About this study
Official title: A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions (0.25% and 0.5%) Compared to Vehicle in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis
A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute Allergic Conjunctivitis
- Conditions
- Allergic Conjunctivitis
- Being tested
- Reproxalap Ophthalmic Solution (0.25%), Reproxalap Ophthalmic Solution (0.5%), Vehicle Ophthalmic Solution
- Keywords
- reproxalap
- 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%) administered once.
Reproxalap Ophthalmic Solution (0.5%)Drug
Reproxalap Ophthalmic Solution (0.5%) administered once.
Vehicle Ophthalmic SolutionDrug
Vehicle Ophthalmic Solution administered once.
| 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
Subject-reported ocular itching score area under the curve from 10 to 60 minutes post allergen challenge using a 0 to 4 scale (0 = none, 4 = severe) was assessed. The least squares mean was derived from analysis of covariance of area under the curve with baseline as a covariate and treatment as a fixed effect The possible range for area under the curve least squares mean is 0 to 100, where a lower score is better.
Measured: Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.
Secondary outcomes (1)
Number of Subjects With Two-point Reduction in Itching Score
The number of within subject 2-point responders (2-point reduction in itch score from 20-60 minutes post-challenge) using a 0 to 4 scale (0 = least, 4 = most) from the 5-minute post-challenge itch score at baseline was assessed.
Measured: Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start30 Mar 2018
- Primary completion5 Nov 2018
- Study completion5 Nov 2018
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 Allergic ConjunctivitisStudies 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
- 318 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
- NCT03494504
- Sponsor's protocol ID
- ADX-102-AC-008
- Status last verified
- Apr 2018
- First submitted
- 4 Apr 2018
- Last updated
- 11 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 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions (0.25% and 0.5%) Compared to Vehicle in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT03494504
- Acronym / sponsor ID
- ADX-102-AC-008
- Conditions
- Allergic Conjunctivitis
- Keywords
- reproxalap
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 5 Nov 2018 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Posted 11 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute Allergic Conjunctivitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 a positive history of ocular allergies and a positive skin test reaction to a seasonal allergen (grasses, ragweed, and/or trees) as confirmed by an allergic skin test at the Screening Visit or within the past 24 months;
- have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart
Key exclusion criteria (6 listed)
- have known contraindications or sensitivities to the use of the investigational product or any of its components
- have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye)
- have had ocular surgical intervention within three (3) months prior to Visit 1 or during the trial and/or a history of refractive surgery six (6) months prior to Visit 1 or have ocular or systemic surgery planned during the study or within 30 days after
- have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
- have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit
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 once. | Drug | Reproxalap Ophthalmic Solution (0.25%) |
| Reproxalap Ophthalmic Solution (0.5%)Reproxalap Ophthalmic Solution (0.5%) administered once. | Drug | Reproxalap Ophthalmic Solution (0.5%) |
| Vehicle Ophthalmic SolutionVehicle Ophthalmic Solution administered once. | Drug | Vehicle Ophthalmic Solution |
Primary outcome
Subject-reported Ocular Itching Score
Time frame: Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.
Subject-reported ocular itching score area under the curve from 10 to 60 minutes post allergen challenge using a 0 to 4 scale (0 = none, 4 = severe) was assessed. The least squares mean was derived from analysis of covariance of area under the curve with baseline as a covariate and treatment as a fixed effect The possible range for area under the curve least squares mean is 0 to 100, where a lower score is better.
1 secondary outcome
Number of Subjects With Two-point Reduction in Itching Score
Time frame: Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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.
7 sites 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%) and Reproxalap Ophthalmic Solution (0.5%) in people with Allergic Conjunctivitis, run by Aldeyra Therapeutics, Inc. at 7 sites 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 6 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 11 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 7 sites 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 11 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 after a single dose; baseline was assessed approximately two weeks before dosing.). 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 11 Feb 2025.