Allergic ConjunctivitisPhase 3NCT00987272
Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis in Japanese Subjects
A Phase 3 study testing Olopatadine Hydrochloride Ophthalmic Solution, 0.2% and Olopatadine Hydrochloride Ophthalmic Solution, 0.1% in people with Allergic Conjunctivitis, run by Alcon Research.
Trial summary
The purpose of the study is to demonstrate safety and efficacy of Olopatadine 0.2% compared to its vehicle in Japanese subjects in the treatment of acute allergen-mediated conjunctivitis using the conjunctival allergen challenge (CAC) test. 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?
- Olopatadine Hydrochloride Ophthalmic Solution, 0.2% and Olopatadine Hydrochloride Ophthalmic Solution, 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Nov 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Japanese ethnicity.
- Seasonal Allergic Conjunctivitis--asymptomatic.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Manifest signs and symptoms of clinically active allergic conjunctivitis in either eye (>1 for redness in any of the 3 vessels beds - conjunctival, episcleral, ciliary - or itching >0) at the start of any visit.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: A Phase III Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the CAC Model of Acute Allergic Conjunctivitis in Japanese Subjects
The purpose of the study is to demonstrate safety and efficacy of Olopatadine 0.2% compared to its vehicle in Japanese subjects in the treatment of acute allergen-mediated conjunctivitis using the conjunctival allergen challenge (CAC) test.
- Conditions
- Allergic Conjunctivitis
- Being tested
- Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, Olopatadine Hydrochloride Ophthalmic Solution, 0.1%, Olopatadine 0.2% Vehicle, Olopatadine 0.1% Vehicle
- Keywords
- Allergies, Ocular
- Medical subject headings
- Conjunctivitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%Drug
Also called PATADAY®
Olopatadine Hydrochloride Ophthalmic Solution, 0.1%Drug
Also called PATANOL®
Olopatadine 0.2% VehicleDrug
Inactive ingredients used as placebo comparator
Olopatadine 0.1% VehicleDrug
Inactive ingredients used as placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Pataday+Pataday Vehicle | Experimental | Olopatadine Hydrochloride Ophthalmic Solution 0.2%, 1 drop in 1 eye and Olopatadine 0.2% Vehicle in the contralateral eye Receives: Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%; Drug: Olopatadine 0.2% Vehicle |
| Patanol+Patanol Vehicle | Active comparator | Olopatadine Hydrochloride Ophthalmic Solution, 0.1%, 1 drop in 1 eye and Olopatadine 0.1% Vehicle in the contralateral eye Receives: Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.1%; Drug: Olopatadine 0.1% Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Ocular Itching Score
Measured: Day 0 of treatment: 3, 5, and 10 minutes post CAC
Secondary outcomes (1)
Mean Total Redness Score
Measured: Day 0 of treatment: 3, 10, 20 minutes post-CAC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ConjunctivitisStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamela Smith, BS, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987272
- Sponsor's protocol ID
- C-09-044
- Status last verified
- Jul 2014
- First submitted
- 28 Sep 2009
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the CAC Model of Acute Allergic Conjunctivitis in Japanese Subjects
- ClinicalTrials.gov ID
- NCT00987272
- Acronym / sponsor ID
- C-09-044
- Conditions
- Allergic Conjunctivitis
- Keywords
- Allergies, Ocular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 30 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to demonstrate safety and efficacy of Olopatadine 0.2% compared to its vehicle in Japanese subjects in the treatment of acute allergen-mediated conjunctivitis using the conjunctival allergen challenge (CAC) test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pataday+Pataday Vehicle | Experimental | Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, Drug: Olopatadine 0.2% VehicleOlopatadine Hydrochloride Ophthalmic Solution 0.2%, 1 drop in 1 eye and Olopatadine 0.2% Vehicle in the contralateral eye |
| Patanol+Patanol Vehicle | Active comparator | Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.1%, Drug: Olopatadine 0.1% VehicleOlopatadine Hydrochloride Ophthalmic Solution, 0.1%, 1 drop in 1 eye and Olopatadine 0.1% Vehicle in the contralateral eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Japanese ethnicity.
- Seasonal Allergic Conjunctivitis--asymptomatic.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (2 listed)
- Manifest signs and symptoms of clinically active allergic conjunctivitis in either eye (>1 for redness in any of the 3 vessels beds - conjunctival, episcleral, ciliary - or itching >0) at the start of any visit.
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| Olopatadine Hydrochloride Ophthalmic Solution, 0.2%Also: PATADAY® | Drug | Pataday+Pataday Vehicle |
| Olopatadine Hydrochloride Ophthalmic Solution, 0.1%Also: PATANOL® | Drug | Patanol+Patanol Vehicle |
| Olopatadine 0.2% VehicleInactive ingredients used as placebo comparator | Drug | Pataday+Pataday Vehicle |
| Olopatadine 0.1% VehicleInactive ingredients used as placebo comparator | Drug | Patanol+Patanol Vehicle |
Primary outcome
Mean Ocular Itching Score
Time frame: Day 0 of treatment: 3, 5, and 10 minutes post CAC
1 secondary outcome
Mean Total Redness Score
Time frame: Day 0 of treatment: 3, 10, 20 minutes post-CAC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
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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.
Pamela Smith, BS study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olopatadine Hydrochloride Ophthalmic Solution, 0.2% and Olopatadine Hydrochloride Ophthalmic Solution, 0.1% in people with Allergic Conjunctivitis, run by Alcon Research.
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 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 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean Ocular Itching Score (time frame: Day 0 of treatment: 3, 5, and 10 minutes post CAC). 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 31 Jul 2014.