Allergic ConjunctivitisPhase 4NCT01109485
Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients
A Phase 4 study testing Olopatadine hydrochloride ophthalmic solution 0.1% in people with Allergic Conjunctivitis, run by Alcon Research at 1 site in Japan.
Trial summary
The objective of this study is to further evaluate the safety of Olopatadine Ophthalmic Solution 0.1% in Japanese children with allergic conjunctivitis. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- Olopatadine hydrochloride ophthalmic solution 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2010to Jul 2011
- Phase
- Phase 4
- 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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients whose parents or guardians can issue informed consent
- Patients aged over 7 and less than 16 at the baseline
- Patients confirmed to show type I allergy
- Patients with allergic conjunctivitis
- Patients having subjective symptoms at the baseline (itching sensation, foreign body sensation, eye pain, etc.)
Who cannot join
- Patients having ocular itching sensation and injection caused by disease other than allergic conjunctivitis
- Patients having retinal detachment, diabetic retinopathy or progressive retinal disease
- Patients with a history of ocular infection, corneal herpes or relapsing corneal erosion of sudden onset or secondary to corneal injury
- Patients having received continuous treatment with corticosteroid within 3 months
- Patients having received immunotherapy
- Patients requiring continuous treatment of corticosteroid, immunosuppressors, non-steroidal anti-inflammatory agents, vasoconstrictors, anti-histamines, anti-allergy agents, herbal preparations indicated for "conjunctivitis" or any ophthalmic solution other than the test product
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- Patients having undergone ocular laser therapy within 3 months
- Unilaterally blind patients (best corrected visual acuity: below 0.01)
- Patients with a history of allergy or hypersensitivity to olopatadine hydrochloride
- Patients necessitating the use of contact lens during the study period
- Other patients judged by the attending physician as inappropriate for study
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to further evaluate the safety of Olopatadine Ophthalmic Solution 0.1% in Japanese children with allergic conjunctivitis.
- Conditions
- Allergic Conjunctivitis
- Being tested
- Olopatadine hydrochloride ophthalmic solution 0.1%
- Keywords
- 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.
Olopatadine hydrochloride ophthalmic solution 0.1%Drug
1-2 drops 4 times per day
| Study group | Role | What they receive |
|---|---|---|
| Olopatadine | Experimental | Olopatadine hydrochloride ophthalmic solution 0.1% Receives: Drug: Olopatadine hydrochloride ophthalmic solution 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: 4 weeks
Questionnaire about compliance with dosing instructions
(1;always >90% 2;often 75-90% 3;sometimes 50-75% 4;seldom <50%)
Measured: 4 weeks
Secondary outcomes (2)
Changes in score of subjective symptoms and objective findings
(0;none 1;mild 2;moderate 3;severe)
Measured: 4 weeks
Questionnaire about stinging after instillation
(1;none 2;mild 3;moderate 4;severe)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2011
- Study completionJul 2011
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eriko Chono, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109485
- Sponsor's protocol ID
- JPN-P-2010-1
- Status last verified
- Sep 2011
- First submitted
- 12 Apr 2010
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients
- ClinicalTrials.gov ID
- NCT01109485
- Acronym / sponsor ID
- JPN-P-2010-1
- Conditions
- Allergic Conjunctivitis
- Keywords
- Allergic conjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 23 Apr 2010 (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 objective of this study is to further evaluate the safety of Olopatadine Ophthalmic Solution 0.1% in Japanese children with allergic conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Olopatadine | Experimental | Drug: Olopatadine hydrochloride ophthalmic solution 0.1%Olopatadine hydrochloride ophthalmic solution 0.1% |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients whose parents or guardians can issue informed consent
- Patients aged over 7 and less than 16 at the baseline
- Patients confirmed to show type I allergy
- Patients with allergic conjunctivitis
- Patients having subjective symptoms at the baseline (itching sensation, foreign body sensation, eye pain, etc.)
Key exclusion criteria (11 listed)
- Patients having ocular itching sensation and injection caused by disease other than allergic conjunctivitis
- Patients having retinal detachment, diabetic retinopathy or progressive retinal disease
- Patients with a history of ocular infection, corneal herpes or relapsing corneal erosion of sudden onset or secondary to corneal injury
- Patients having received continuous treatment with corticosteroid within 3 months
- Patients having received immunotherapy
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 0.1%1-2 drops 4 times per day | Drug | Olopatadine |
Primary outcome
Incidence of adverse events
Time frame: 4 weeks
Questionnaire about compliance with dosing instructions
Time frame: 4 weeks
(1;always >90% 2;often 75-90% 3;sometimes 50-75% 4;seldom <50%)
2 secondary outcomes
Changes in score of subjective symptoms and objective findings
Time frame: 4 weeks
Questionnaire about stinging after instillation
Time frame: 4 weeks
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 12 May 2015.
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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.
Eriko Chono study director
Alcon Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olopatadine hydrochloride ophthalmic solution 0.1% in people with Allergic Conjunctivitis, run by Alcon Research 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 5 inclusion and 11 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 12 May 2015. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Incidence of adverse events (time frame: 4 weeks). The study lists 2 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 12 May 2015.