Allergic ConjunctivitisPhase 2NCT02578914
A Safety and Activity Study of NS2 in Subjects With Allergic Conjunctivitis
A Phase 2 study testing NS2 Ophthalmic Drops (0.5%) in people with Allergic Conjunctivitis and Seasonal Allergies, run by Aldeyra Therapeutics, Inc. at 1 site in Canada.
Trial summary
This is a randomized, parallel, single center, double masked, vehicle controlled study. The purpose of this study is to determine the activity and safety of NS2 in patients with grass, tree or ragweed-pollen induced seasonal allergic conjunctivitis . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Conjunctivitis, Seasonal Allergies
- What is being tested?
- NS2 Ophthalmic Drops (0.5%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Dec 2015
- 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
- Graded conjunctival redness in at least one region (nasal or temporal) in each eye at any one time point (not necessarily the same time point) post-CAPT (Conjunctival Allergen Provocation Test) of >2
- Graded ocular itching at any one time point
- Visual acuity of at least 20/50 in each eye
- At least 2 year history of moderate to severe allergic conjunctivitis.
- Positive skin prick test to ragweed, grass and/or tree pollen within one year of Screening Visit (Visit 1).
- Ability to avoid any topical or systemic ocular medications during the entire study period.
Who cannot join
- Subjects must not have an ocular itching score >0 or a conjunctival redness score >1 prior to CAPT in either eye in any region (nasal or temporal) at Visits 2-4. I
- History of glaucoma, or Intraocular Pressure (IOP) over 25mmHg at the screening visit, or a history of elevated IOP within the past 1 year.
- Ocular surgery, including laser procedures, within the past 12 months of Visit 1.
- Use of glaucoma medications, antibiotics, antivirals, or topical cyclosporine within 1 month of the screening visit.
- History of dry eye syndrome, blepharitis, herpes simplex keratitis or herpes zoster keratitis.
- History of uveitis in the past 3 years.
Show all 10Show fewer
- Presence of any ocular infection or active ocular inflammation (e.g. follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to start of study (Visit 1).
- History of moderate to severe asthma or allergy induced asthma to the allergen that will be used in CAPT.
- Use of oral corticosteroids within 30 days of screening and throughout the study period; use of intranasal or inhaled corticosteroids within 14 days of screening and throughout the study period.
- Use of antihistamines (ocular, nasal, topical or oral) within 7 days prior to screening (Visit 1) and throughout the study period. Non-medicated artificial tears are allowed up to 72 hours before screening (Visit 1) and throughout the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Parallel, Single-Center, Double-Masked, Vehicle-Controlled Phase II Study to Evaluate the Activity of NS2 Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using the Conjunctival Allergen Provocation Test (CAPT)
This is a randomized, parallel, single center, double masked, vehicle controlled study. The purpose of this study is to determine the activity and safety of NS2 in patients with grass, tree or ragweed-pollen induced seasonal allergic conjunctivitis . Subjects will be randomized 1:1 to receive multiple doses of NS2 Ophthalmic Drops (0.5%) or NS2 Ophthalmic Drops Vehicle (0.0%).
Free aldehydes are thought to be related to inflammatory conditions such as allergic conjunctivitis. NS2, a small molecule aldehyde trap, is being evaluated to determine whether it may decrease inflammation by lowering aldehyde levels.
- Conditions
- Allergic Conjunctivitis, Seasonal Allergies
- Being tested
- NS2 Ophthalmic Drops (0.5%), NS2 Ophthalmic Drops Vehicle (0.0%)
- Keywords
- allergic conjunctivitis, seasonal allergies, ragweed allergy, grass allergy, tree allergy, NS2, Aldeyra
- Medical subject headings
- Conjunctivitis, Allergic, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NS2 Ophthalmic Drops (0.5%)Drug
NS2 Ophthalmic Drops Vehicle (0.0%)Drug
| Study group | Role | What they receive |
|---|---|---|
| NS2 Ophthalmic Drops (0.5%) | Experimental | NS2 Ophthalmic Drops (0.5%) Receives: Drug: NS2 Ophthalmic Drops (0.5%) |
| NS2 Ophthalmic Drops Vehicle (0.0%) | Sham comparator | NS2 Ophthalmic Drops Vehicle (0.0%) control Receives: Drug: NS2 Ophthalmic Drops Vehicle (0.0%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Itching Score at Day 14, 60 Minutes Into the Allergen Challenge
Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = none, 4 = severe) on Day 14, 60 minutes into the allergen challenge. The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor.
Measured: The efficacy assessment period was assessed at Day 14; baseline was Day -7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionDec 2015
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aldeyra Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Couroux, Principal investigator, Inflamax Research Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578914
- Sponsor's protocol ID
- ALDNS2-203-D1
- Other IDs
- 15-MO-001
- Status last verified
- May 2016
- First submitted
- 8 Oct 2015
- Last updated
- 5 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel, Single-Center, Double-Masked, Vehicle-Controlled Phase II Study to Evaluate the Activity of NS2 Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using the Conjunctival Allergen Provocation Test (CAPT)
- ClinicalTrials.gov ID
- NCT02578914
- Acronym / sponsor ID
- ALDNS2-203-D1
- Conditions
- Allergic Conjunctivitis, Seasonal Allergies
- Keywords
- allergic conjunctivitis, seasonal allergies, ragweed allergy, grass allergy, tree allergy, NS2, Aldeyra
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Posted 5 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, parallel, single center, double masked, vehicle controlled study. The purpose of this study is to determine the activity and safety of NS2 in patients with grass, tree or ragweed-pollen induced seasonal allergic conjunctivitis . Subjects will be randomized 1:1 to receive multiple doses of NS2 Ophthalmic Drops (0.5%) or NS2 Ophthalmic Drops Vehicle (0.0%).
Free aldehydes are thought to be related to inflammatory conditions such as allergic conjunctivitis. NS2, a small molecule aldehyde trap, is being evaluated to determine whether it may decrease inflammation by lowering aldehyde levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NS2 Ophthalmic Drops (0.5%) | Experimental | Drug: NS2 Ophthalmic Drops (0.5%)NS2 Ophthalmic Drops (0.5%) |
| NS2 Ophthalmic Drops Vehicle (0.0%) | Sham comparator | Drug: NS2 Ophthalmic Drops Vehicle (0.0%)NS2 Ophthalmic Drops Vehicle (0.0%) control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Graded conjunctival redness in at least one region (nasal or temporal) in each eye at any one time point (not necessarily the same time point) post-CAPT (Conjunctival Allergen Provocation Test) of >2
- Graded ocular itching at any one time point
- Visual acuity of at least 20/50 in each eye
- At least 2 year history of moderate to severe allergic conjunctivitis.
- Positive skin prick test to ragweed, grass and/or tree pollen within one year of Screening Visit (Visit 1).
Key exclusion criteria (10 listed)
- Subjects must not have an ocular itching score >0 or a conjunctival redness score >1 prior to CAPT in either eye in any region (nasal or temporal) at Visits 2-4. I
- History of glaucoma, or Intraocular Pressure (IOP) over 25mmHg at the screening visit, or a history of elevated IOP within the past 1 year.
- Ocular surgery, including laser procedures, within the past 12 months of Visit 1.
- Use of glaucoma medications, antibiotics, antivirals, or topical cyclosporine within 1 month of the screening visit.
- History of dry eye syndrome, blepharitis, herpes simplex keratitis or herpes zoster keratitis.
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 |
|---|---|---|
| NS2 Ophthalmic Drops (0.5%) | Drug | NS2 Ophthalmic Drops (0.5%) |
| NS2 Ophthalmic Drops Vehicle (0.0%) | Drug | NS2 Ophthalmic Drops Vehicle (0.0%) |
Primary outcome
Ocular Itching Score at Day 14, 60 Minutes Into the Allergen Challenge
Time frame: The efficacy assessment period was assessed at Day 14; baseline was Day -7.
Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = none, 4 = severe) on Day 14, 60 minutes into the allergen challenge. The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- 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.
Peter Couroux principal investigator
Inflamax Research Incorporated
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 NS2 Ophthalmic Drops (0.5%) in people with Allergic Conjunctivitis and Seasonal Allergies, 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 6 inclusion and 10 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 5 Dec 2023. 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 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 5 Dec 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 Score at Day 14, 60 Minutes Into the Allergen Challenge (time frame: The efficacy assessment period was assessed at Day 14; baseline was Day -7.). 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 5 Dec 2023.