Allergic ConjunctivitisPhase 2NCT01754766
AGN-229666 for the Treatment of Allergic Conjunctivitis
A Phase 2 study testing AGN-229666 in people with Allergic Conjunctivitis, run by Allergan at 1 site in Japan.
Trial summary
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic conjunctivitis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- AGN-229666
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2012to Feb 2013
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese patients living in Japan with a history of allergic conjunctivitis
- Willing to discontinue wearing contact lenses during the study period
Who cannot join
- Use of nicotine products during the study period
- Presence of active eye infection (bacterial, viral, or fungal)
- History of an ocular herpetic infection
- Eye surgery intervention within 3 months and/or a history of refractive surgery within the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic conjunctivitis.
- Conditions
- Allergic Conjunctivitis
- Being tested
- AGN-229666, vehicle of AGN-229666
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN-229666Drug
One drop of AGN-229666 into each eye on Day 1 and Day 15.
vehicle of AGN-229666Other
One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
| Study group | Role | What they receive |
|---|---|---|
| AGN-229666 Dose A | Experimental | One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15. Receives: Drug: AGN-229666 |
| AGN-229666 Dose B | Experimental | One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15. Receives: Drug: AGN-229666 |
| vehicle of AGN-229666 | Placebo comparator | One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15. Receives: Other: vehicle of AGN-229666 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Itching Score at Day 1
The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (CAC) (8 hours post-dose) at Day 1 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.
Measured: Day 1
Secondary outcomes (2)
Ocular Itching Score at Day 15
The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (16 hours post-dose) at Day 15 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.
Measured: Day 15
Conjunctival Hyperemia Score
Conjunctival hyperemia is the engorgement of the blood vessels (redness) of the clear membrane covering the white surface of the eye. Conjunctival hyperemia was evaluated 15 minutes post conjunctival allergen challenge (CAC) (8 hours post dose) on Day 1 for both eyes using a 9-point scale in half-unit increments where: 0=none to 4=Extremely severe. The score for each participant was the average of the score of both eyes.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2013
- Study completionFeb 2013
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754766
- Sponsor's protocol ID
- 229666-002
- Status last verified
- Dec 2013
- First submitted
- 19 Dec 2012
- Last updated
- 4 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AGN-229666 for the Treatment of Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT01754766
- Acronym / sponsor ID
- 229666-002
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Posted 4 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AGN-229666 Dose A | Experimental | Drug: AGN-229666One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15. |
| AGN-229666 Dose B | Experimental | Drug: AGN-229666One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15. |
| vehicle of AGN-229666 | Placebo comparator | Other: vehicle of AGN-229666One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Japanese patients living in Japan with a history of allergic conjunctivitis
- Willing to discontinue wearing contact lenses during the study period
Key exclusion criteria (4 listed)
- Use of nicotine products during the study period
- Presence of active eye infection (bacterial, viral, or fungal)
- History of an ocular herpetic infection
- Eye surgery intervention within 3 months and/or a history of refractive surgery within the past 6 months
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 |
|---|---|---|
| AGN-229666One drop of AGN-229666 into each eye on Day 1 and Day 15. | Drug | AGN-229666 Dose A, AGN-229666 Dose B |
| vehicle of AGN-229666One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15. | Other | vehicle of AGN-229666 |
Primary outcome
Ocular Itching Score at Day 1
Time frame: Day 1
The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (CAC) (8 hours post-dose) at Day 1 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.
2 secondary outcomes
Ocular Itching Score at Day 15
Time frame: Day 15
Conjunctival Hyperemia Score
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
- 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.
Medical Director study director
Allergan
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 AGN-229666 in people with Allergic Conjunctivitis, run by Allergan at 1 site in Japan.
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 2 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 4 Feb 2014. 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 Japan. 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 4 Feb 2014). 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 1 (time frame: Day 1). 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 4 Feb 2014.