Allergic ConjunctivitisPhase 4NCT01272089
A Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis
A Phase 4 study testing Olopatadine Hydrochloride Ophthalmic Solution, 0.2% in people with Allergic Conjunctivitis, run by Alcon Research at 1 site in India.
Trial summary
The purpose of this study was to evaluate subject perceptions of Olopatadine 0.2%, dosed once-daily, in subjects with allergic conjunctivitis and to record any adverse events as described by the subjects as a part of this post marketing surveillance study. 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%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIndia
- Study dates
- May 2011to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History (within the past 24 months) of allergic conjunctivitis.
- Willing to avoid contact lens wear for each of the study visits, immediately prior to study medication installation and for 10 minutes after installation of study drug.
- Contact lens wear should be stable and consistent for 3 months prior to Screening Visit (Day 1).
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Contraindications or hypersensitivity to the use of the study medication or its components.
- Inability or unwillingness to follow all study instructions and complete study visits as required.
- Subjects with only one sighted eye or not correctable (using ETDRS chart) to 0.6 log MAR or better in both eyes at the Screening Visit.
- A known history of recurrent corneal erosion syndrome (idiopathic or secondary to dry eye).
- Ocular trauma within six months prior to Visit 1 in either eye as determined by subject history and/or examination.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Site, Open-Label Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis
The purpose of this study was to evaluate subject perceptions of Olopatadine 0.2%, dosed once-daily, in subjects with allergic conjunctivitis and to record any adverse events as described by the subjects as a part of this post marketing surveillance study.
- Conditions
- Allergic Conjunctivitis
- Being tested
- Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
- 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, 0.2%Drug
Also called Pataday
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once a day for one week
| Study group | Role | What they receive |
|---|---|---|
| Pataday | Experimental | Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once daily for one week Receives: Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Patient Satisfaction
As assessed by the subject on a questionnaire
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2011
- Study completionDec 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
- 300 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
- NCT01272089
- Sponsor's protocol ID
- C-11-013
- Status last verified
- Sep 2012
- First submitted
- 5 Jan 2011
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site, Open-Label Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT01272089
- Acronym / sponsor ID
- C-11-013
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Jan 2011 (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 this study was to evaluate subject perceptions of Olopatadine 0.2%, dosed once-daily, in subjects with allergic conjunctivitis and to record any adverse events as described by the subjects as a part of this post marketing surveillance study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pataday | Experimental | Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once daily for one week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History (within the past 24 months) of allergic conjunctivitis.
- Willing to avoid contact lens wear for each of the study visits, immediately prior to study medication installation and for 10 minutes after installation of study drug.
- Contact lens wear should be stable and consistent for 3 months prior to Screening Visit (Day 1).
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (6 listed)
- Contraindications or hypersensitivity to the use of the study medication or its components.
- Inability or unwillingness to follow all study instructions and complete study visits as required.
- Subjects with only one sighted eye or not correctable (using ETDRS chart) to 0.6 log MAR or better in both eyes at the Screening Visit.
- A known history of recurrent corneal erosion syndrome (idiopathic or secondary to dry eye).
- Ocular trauma within six months prior to Visit 1 in either eye as determined by subject history and/or examination.
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: PatadayOlopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once a day for one week | Drug | Pataday |
Primary outcome
Overall Patient Satisfaction
Time frame: Day 7
As assessed by the subject on a questionnaire
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 18 Sep 2012.
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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.
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, 0.2% in people with Allergic Conjunctivitis, run by Alcon Research at 1 site in India.
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 6 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 18 Sep 2012. 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 India. 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?
Overall Patient Satisfaction (time frame: Day 7). 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 18 Sep 2012.