Conjunctivitis, AllergicPhase 2NCT03012165
A Study of ADX-102 in Subjects With Allergic Conjunctivitis
A Phase 2 study testing ADX-102 Ophthalmic Drops (0.5%) and ADX-102 Ophthalmic Drops (0.1%) in people with Conjunctivitis, Allergic, run by Aldeyra Therapeutics, Inc. at 5 sites in United States.
Trial summary
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2b Evaluation of the Onset and Duration of ADX-102 Ophthalmic Drops (0.5% and 0.1%) Compared to Vehicle of ADX-102 Ophthalmic Drops in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis. 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?
- ADX-102 Ophthalmic Drops (0.5%) and ADX-102 Ophthalmic Drops (0.1%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2016to May 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 positive history of ocular allergies and a positive skin test reaction to a seasonal (grasses, ragweed, and/or trees) or perennial allergen (cat dander, dog dander, dust mites, cockroach) as confirmed by an allergic skin test 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 study and/or a history of refractive surgery within the past six (6) months
- 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 study duration and for 14 days prior to the installation of investigational product, or has a positive urine pregnancy test at Visit 1
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Silverstein Eye Centers
Kansas City, Missouri, 64133
Apex Eye Clinical Research
Mason, Ohio, 45040
Total Eye Care
Memphis, Tennessee, 38119
Eye Care Centers Management
Morrow, Georgia, 30260
Philadelphia Eye Associates
Philadelphia, Pennsylvania, 19148
About this study
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2b Evaluation of the Onset and Duration of ADX-102 Ophthalmic Drops (0.5% and 0.1%) Compared to Vehicle of ADX-102 Ophthalmic Drops in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis.
- Conditions
- Conjunctivitis, Allergic
- Being tested
- ADX-102 Ophthalmic Drops (0.5%), ADX-102 Ophthalmic Drops (0.1%), Vehicle of ADX-102 Ophthalmic Drops
- Keywords
- 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.
ADX-102 Ophthalmic Drops (0.5%)Drug
ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
ADX-102 Ophthalmic Drops (0.1%)Drug
ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
Vehicle of ADX-102 Ophthalmic DropsDrug
Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.
| Study group | Role | What they receive |
|---|---|---|
| ADX-102 Ophthalmic Drops (0.5%) | Experimental | ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks. Receives: Drug: ADX-102 Ophthalmic Drops (0.5%) |
| ADX-102 Ophthalmic Drops (0.1%) | Experimental | ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks. Receives: Drug: ADX-102 Ophthalmic Drops (0.1%) |
| Vehicle of ADX-102 Ophthalmic Drops | Placebo comparator | Vehicle of ADX-102 Ophthalmic Drops Receives: Drug: Vehicle of ADX-102 Ophthalmic Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching 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 15), Day 15 reported.
Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching 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 15), Day 15 reported.
Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching 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 15), Day 15 reported.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionMay 2017
- Study completionMay 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aldeyra Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012165
- Sponsor's protocol ID
- ADX-102-AC-004
- Status last verified
- Dec 2022
- First submitted
- 14 Dec 2016
- Last updated
- 9 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of ADX-102 in Subjects With Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT03012165
- Acronym / sponsor ID
- ADX-102-AC-004
- Conditions
- Conjunctivitis, Allergic
- Keywords
- ADX-102, Allergic Conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- Dec 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Posted 9 Jan 2023
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, Vehicle-Controlled, Phase 2b Evaluation of the Onset and Duration of ADX-102 Ophthalmic Drops (0.5% and 0.1%) Compared to Vehicle of ADX-102 Ophthalmic Drops in the Conjunctival Allergen Challenge (Ora-CAC®) Model of 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 |
|---|---|---|
| ADX-102 Ophthalmic Drops (0.5%) | Experimental | Drug: ADX-102 Ophthalmic Drops (0.5%)ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks. |
| ADX-102 Ophthalmic Drops (0.1%) | Experimental | Drug: ADX-102 Ophthalmic Drops (0.1%)ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks. |
| Vehicle of ADX-102 Ophthalmic Drops | Placebo comparator | Drug: Vehicle of ADX-102 Ophthalmic DropsVehicle of ADX-102 Ophthalmic Drops |
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 (grasses, ragweed, and/or trees) or perennial allergen (cat dander, dog dander, dust mites, cockroach) as confirmed by an allergic skin test 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 study and/or a history of refractive surgery within the past six (6) months
- 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 |
|---|---|---|
| ADX-102 Ophthalmic Drops (0.5%)ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks. | Drug | ADX-102 Ophthalmic Drops (0.5%) |
| ADX-102 Ophthalmic Drops (0.1%)ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks. | Drug | ADX-102 Ophthalmic Drops (0.1%) |
| Vehicle of ADX-102 Ophthalmic DropsVehicle of ADX-102 Ophthalmic Drops administered twice in two weeks. | Drug | Vehicle of ADX-102 Ophthalmic Drops |
Primary outcome
Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
Time frame: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
Time frame: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
Time frame: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADX-102 Ophthalmic Drops (0.5%) and ADX-102 Ophthalmic Drops (0.1%) in people with Conjunctivitis, Allergic, run by Aldeyra Therapeutics, Inc. at 5 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 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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 9 Jan 2023). 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?
Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. (time frame: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.). The study lists 3 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 9 Jan 2023.