Allergic ConjunctivitisPhase 4NCT00818805
Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)
A Phase 4 study testing Olopatadine 0.1% and Tranilast 0.5% in people with Allergic Conjunctivitis, run by Alcon Research.
Trial summary
To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal allergic conjunctivitis. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- Olopatadine 0.1% and Tranilast 0.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Jul 2008
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age/Gender: males and females aged >20 to < 65 years (at the time of obtaining consent).
- Positive cases in whom blood specific IgE antibody quantification against cedar pollen showed class 2-6 in a health checkup conducted within the past 3 years.
- Cases who were diagnosed as patients with seasonal allergic conjunctivitis and were judged eligible as subjects of the said study by the investigator or co-investigator from the results of medical examination conducted on the day of the study or prior to it.
- Cases who gave consent on study participation of their own free will in writing, with understanding the contents of the said study.
Who cannot join
- Cases with an ocular disease that requires treatment other than allergic conjunctivitis.
- Cases with an inflammatory ocular disease in the external/anterior part of the eye that may affect drug efficacy evaluation.
- Cases with a respiratory disease such as bronchial asthma other than allergic rhinitis.
- Cases with past history of anaphylaxis.
- Cases with past history of hypersensitivity to olopatadine hydrochloride/tranilast.
- Cases undergoing immunotherapy (hyposensitization therapy; modulated therapy).
- Patients who are pregnant, lactating women, or may be pregnant, or cases wishing to be pregnant during the study period.
- Other cases who are judged ineligible for participation in the main study by the doctor in charge of the study.
About this study
To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal allergic conjunctivitis.
- Conditions
- Allergic Conjunctivitis
- Being tested
- Olopatadine 0.1%, Tranilast 0.5%, Placebo (Olopatadine), Placebo (Tranilast)
- Keywords
- conjunctivitis
- Medical subject headings
- Conjunctivitis, Allergic, Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olopatadine 0.1%Drug
one drop in one eye
Tranilast 0.5%Drug
one drop in one eye
Placebo (Olopatadine)Drug
one drop in contralateral eye
Placebo (Tranilast)Drug
one drop in contralateral eye
| Study group | Role | What they receive |
|---|---|---|
| Olopatadine 0.1% one eye | Experimental | Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye Receives: Drug: Olopatadine 0.1% |
| Tranilast 0.5% one eye | Experimental | Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye Receives: Drug: Tranilast 0.5% |
| Placebo (Olopatadine) | Placebo comparator | Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye Receives: Drug: Placebo (Olopatadine) |
| Placebo (Tranilast) | Placebo comparator | Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye Receives: Drug: Placebo (Tranilast) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching.
Measured: 0-180 minutes after entering the examination room
Secondary outcomes (1)
Change in Total Score in Ocular Symptom Questionnaire
Measured: 15-180 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2009 (estimated)
- Study startJul 2008
- Primary completionJul 2008
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.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818805
- Sponsor's protocol ID
- AL-292ET
- Status last verified
- Mar 2010
- First submitted
- 7 Jan 2009
- Last updated
- 4 Jun 2012
- 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 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)
- ClinicalTrials.gov ID
- NCT00818805
- Acronym / sponsor ID
- AL-292ET
- Conditions
- Allergic Conjunctivitis
- Keywords
- conjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jul 2008 (actual)
- First posted
- 8 Jan 2009 (estimated)
- Results
- Posted 15 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal allergic conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Olopatadine 0.1% one eye | Experimental | Drug: Olopatadine 0.1%Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye |
| Tranilast 0.5% one eye | Experimental | Drug: Tranilast 0.5%Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye |
| Placebo (Olopatadine) | Placebo comparator | Drug: Placebo (Olopatadine)Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye |
| Placebo (Tranilast) | Placebo comparator | Drug: Placebo (Tranilast)Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age/Gender: males and females aged >20 to < 65 years (at the time of obtaining consent).
- Positive cases in whom blood specific IgE antibody quantification against cedar pollen showed class 2-6 in a health checkup conducted within the past 3 years.
- Cases who were diagnosed as patients with seasonal allergic conjunctivitis and were judged eligible as subjects of the said study by the investigator or co-investigator from the results of medical examination conducted on the day of the study or prior to it.
- Cases who gave consent on study participation of their own free will in writing, with understanding the contents of the said study.
Key exclusion criteria (8 listed)
- Cases with an ocular disease that requires treatment other than allergic conjunctivitis.
- Cases with an inflammatory ocular disease in the external/anterior part of the eye that may affect drug efficacy evaluation.
- Cases with a respiratory disease such as bronchial asthma other than allergic rhinitis.
- Cases with past history of anaphylaxis.
- Cases with past history of hypersensitivity to olopatadine hydrochloride/tranilast.
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 0.1%one drop in one eye | Drug | Olopatadine 0.1% one eye |
| Tranilast 0.5%one drop in one eye | Drug | Tranilast 0.5% one eye |
| Placebo (Olopatadine)one drop in contralateral eye | Drug | Placebo (Olopatadine) |
| Placebo (Tranilast)one drop in contralateral eye | Drug | Placebo (Tranilast) |
Primary outcome
Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
Time frame: 0-180 minutes after entering the examination room
Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching.
1 secondary outcome
Change in Total Score in Ocular Symptom Questionnaire
Time frame: 15-180 min.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olopatadine 0.1% and Tranilast 0.5% 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 4 inclusion and 8 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 Jun 2012. 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. 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 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?
Yes. Results are posted in the registry (first posted 15 Mar 2010). 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?
Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire (time frame: 0-180 minutes after entering the examination room). 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 Jun 2012.