Allergic ConjunctivitisPhase 4NCT01159769
Patient Perceptions and Quality of Life Associated With the Use of Olapatadine 0.2% for the Treatment of Allergic Conjunctivitis
A Phase 4 study testing Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®) in people with Allergic Conjunctivitis, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate patient perceptions of olopatadine 0.2% dosed once daily in patients previously treated with twice-daily, topical, ocular, anti-allergy medications. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Aug 2010
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 12 years of age or older.
- History (within the past 24 months) of allergic conjunctivitis.
- Active signs and symptoms of ocular allergies.
- Ocular health within normal limits, as determined by the investigator or subinvestigator.
- Willing to avoid contact lens wear each study visit immediately prior to study medication instillation and for 10 minutes after instillation of study drug.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Contraindications or hypersensitivity to study medication or its components.
- One sighted eye or not correctable to 0.6 logMAR or better in both eyes at the screening visit.
- Known history of recurrent corneal erosion syndrome.
- Ocular trauma or surgical intervention within 6 months prior to Visit 1.
- Participation in any other investigational study within 30 days before Visit 1.
- Pregnant or nursing.
- Other protocol-defined exclusion criteria may apply.
About this study
The purpose of this study is to evaluate patient perceptions of olopatadine 0.2% dosed once daily in patients previously treated with twice-daily, topical, ocular, anti-allergy medications.
- Conditions
- Allergic Conjunctivitis
- Being tested
- Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)
- 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, 0.2% (Pataday®)Drug
Also called Pataday®
Commercially marketed ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis
| Study group | Role | What they receive |
|---|---|---|
| Olopatadine 0.2% | Experimental | 1 drop self-administered in each eye once daily in the morning for 7 days Receives: Drug: Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Patient Satisfaction
Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, "Overall, how satisfied are you with your current eye allergy medication?" A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, "very satisfied" or "satisfied."
Measured: Day 0
Overall Patient Satisfaction
Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, "Overall, how satisfied were you with olopatadine 0.2%?" A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, "very satisfied" or "satisfied."
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 posted9 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2010
- Study completionAug 2010
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 215 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
- NCT01159769
- Sponsor's protocol ID
- SMA-10-13
- Status last verified
- Mar 2012
- First submitted
- 8 Jul 2010
- Last updated
- 3 Apr 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 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Perceptions and Quality of Life Associated With the Use of Olapatadine 0.2% for the Treatment of Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT01159769
- Acronym / sponsor ID
- SMA-10-13
- Conditions
- Allergic Conjunctivitis
- Keywords
- Allergic conjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 Jul 2010 (estimated)
- Results
- Posted 3 Apr 2012
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 is to evaluate patient perceptions of olopatadine 0.2% dosed once daily in patients previously treated with twice-daily, topical, ocular, anti-allergy medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Olopatadine 0.2% | Experimental | Drug: Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)1 drop self-administered in each eye once daily in the morning for 7 days |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 12 years of age or older.
- History (within the past 24 months) of allergic conjunctivitis.
- Active signs and symptoms of ocular allergies.
- Ocular health within normal limits, as determined by the investigator or subinvestigator.
- Willing to avoid contact lens wear each study visit immediately prior to study medication instillation and for 10 minutes after instillation of study drug.
Key exclusion criteria (7 listed)
- Contraindications or hypersensitivity to study medication or its components.
- One sighted eye or not correctable to 0.6 logMAR or better in both eyes at the screening visit.
- Known history of recurrent corneal erosion syndrome.
- Ocular trauma or surgical intervention within 6 months prior to Visit 1.
- Participation in any other investigational study within 30 days before Visit 1.
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% (Pataday®)Also: Pataday®Commercially marketed ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis | Drug | Olopatadine 0.2% |
Primary outcome
Overall Patient Satisfaction
Time frame: Day 0
Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, "Overall, how satisfied are you with your current eye allergy medication?" A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, "very satisfied" or "satisfied."
Overall Patient Satisfaction
Time frame: Day 7
Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, "Overall, how satisfied were you with olopatadine 0.2%?" A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, "very satisfied" or "satisfied."
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 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 hydrochloride ophthalmic solution, 0.2% (Pataday®) 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 6 inclusion and 7 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 3 Apr 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. 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 3 Apr 2012). 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?
Overall Patient Satisfaction (time frame: Day 0). 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 3 Apr 2012.