Conjunctivitis, AllergicPhase 3NCT02161146
AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis
A Phase 3 study testing AGN-229666 and Olopatadine in people with Conjunctivitis, Allergic, run by Allergan at 1 site in Japan.
Trial summary
This study will evaluate the safety and efficacy of AGN-229666 for the prevention of allergen-mediated conjunctivitis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Conjunctivitis, Allergic
- What is being tested?
- AGN-229666 and Olopatadine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteJapan
- Study dates
- 4 Jun 2014to 20 Dec 2014
- 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 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.
Who cannot join
- Presence of active eye infection (bacterial, viral, or fungal)
- History of an eye herpetic infection.
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 prevention of allergen-mediated conjunctivitis.
- Conditions
- Conjunctivitis, Allergic
- Being tested
- AGN-229666, Vehicle to AGN-229666, Olopatadine
- 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 in the eye on Days 1 and 15.
Vehicle to AGN-229666Drug
One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.
OlopatadineDrug
Also called Patanol®
One drop of olopatadine in the eye on Days 1 and 15.
| Study group | Role | What they receive |
|---|---|---|
| AGN-229666 | Experimental | One drop of AGN-229666 in each eye on Days 1 and 15. Receives: Drug: AGN-229666 |
| Vehicle | Placebo comparator | One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15. Receives: Drug: Vehicle to AGN-229666 |
| Olopatadine | Active comparator | One drop of olopatadine in each eye on Days 1 and 15. Receives: Drug: Olopatadine |
| AGN-229666/Olopatadine | Other | One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15. Receives: Drug: AGN-229666; Drug: Olopatadine |
| AGN-229666/Vehicle | Other | One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15. Receives: Drug: AGN-229666; Drug: Vehicle to AGN-229666 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Itching Score
Ocular itching was assessed by the participant 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 5 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no itching) to 4.0=incapacitating itch with an irresistible urge to rub (worst). Data from Days 1 and 15 were pooled together and averaged.
Measured: Days 1 and 15
Secondary outcomes (1)
Conjunctival Hyperemia Score
Hyperemia is the engorgement of the blood vessels (redness) of the eye. Ocular hyperemia was evaluated by the investigator 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 15 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no hyperemia) to 4.0=extremely severe (large, numerous dilated blood vessels characterized by severe deep red color). Data from Days 1 and 15 were pooled together and averaged.
Measured: Days 1 and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study start4 Jun 2014
- Primary completion20 Dec 2014
- Study completion20 Dec 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 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
- NCT02161146
- Sponsor's protocol ID
- 229666-006
- Status last verified
- Apr 2019
- First submitted
- 9 Jun 2014
- Last updated
- 17 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Nakatani H, Gomes P, Bradford R, Guo Q, Safyan E, Hollander DA. Alcaftadine 0.25% versus Olopatadine 0.1% in Preventing Cedar Pollen Allergic Conjunctivitis in Japan: A Randomized Study. Ocul Immunol Inflamm. 2019;27(4):622-631. doi: 10.1080/09273948.2018.1432764. Epub 2018 Mar 15.
PubMed 29543548
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT02161146
- Acronym / sponsor ID
- 229666-006
- Conditions
- Conjunctivitis, Allergic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2014 (actual)
- Primary completion
- 20 Dec 2014 (actual)
- Study completion
- 20 Dec 2014 (actual)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Posted 7 Mar 2016
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 prevention of allergen-mediated conjunctivitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AGN-229666 | Experimental | Drug: AGN-229666One drop of AGN-229666 in each eye on Days 1 and 15. |
| Vehicle | Placebo comparator | Drug: Vehicle to AGN-229666One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15. |
| Olopatadine | Active comparator | Drug: OlopatadineOne drop of olopatadine in each eye on Days 1 and 15. |
| AGN-229666/Olopatadine | Other | Drug: AGN-229666, Drug: OlopatadineOne drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15. |
| AGN-229666/Vehicle | Other | Drug: AGN-229666, Drug: Vehicle to AGN-229666One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Japanese patients living in Japan with a history of allergic conjunctivitis.
Key exclusion criteria (2 listed)
- Presence of active eye infection (bacterial, viral, or fungal)
- History of an eye herpetic infection.
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 in the eye on Days 1 and 15. | Drug | AGN-229666, AGN-229666/Olopatadine, AGN-229666/Vehicle |
| Vehicle to AGN-229666One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15. | Drug | AGN-229666/Vehicle, Vehicle |
| OlopatadineAlso: Patanol®One drop of olopatadine in the eye on Days 1 and 15. | Drug | AGN-229666/Olopatadine, Olopatadine |
Primary outcome
Ocular Itching Score
Time frame: Days 1 and 15
Ocular itching was assessed by the participant 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 5 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no itching) to 4.0=incapacitating itch with an irresistible urge to rub (worst). Data from Days 1 and 15 were pooled together and averaged.
1 secondary outcome
Conjunctival Hyperemia Score
Time frame: Days 1 and 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29543548Nakatani H, Gomes P, Bradford R, Guo Q, Safyan E, Hollander DA. Alcaftadine 0.25% versus Olopatadine 0.1% in Preventing Cedar Pollen Allergic Conjunctivitis in Japan: A Randomized Study. Ocul Immunol Inflamm. 2019;27(4):622-631. doi: 10.1080/09273948.2018.1432764. Epub 2018 Mar 15.
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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 3 study testing AGN-229666 and Olopatadine in people with Conjunctivitis, Allergic, 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 1 inclusion and 2 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 17 Apr 2019. 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 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 7 Mar 2016). 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 (time frame: Days 1 and 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02161146, which also lists 1 linked publication.
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 17 Apr 2019.