Allergic ConjunctivitisPhase 4NCT01697969
Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients
A Phase 4 study testing Olopatadine hydrochloride ophthalmic solution, 0.2% in people with Allergic Conjunctivitis, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to descriptively evaluate the corneal structures of allergic conjunctivitis patients. 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
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jul 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Read, sign, and date an Ethics Committee reviewed and approved informed consent form.
- Females of childbearing potential who:
- Are not breast-feeding;
- Do not intend to become pregnant for the duration of the study;
- Are using adequate birth control methods and agree to continue for the duration of the study.
- Able to read, understand and answer questions by investigator.
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- Willing and able to attend all required study visits and follow directions as stipulated by the protocol and investigator.
- History of allergic conjunctivitis (within the past 12 months) and active signs and symptoms of ocular allergies for which treatment is necessary, in the opinion of the investigator.
- Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with or without glasses correction.
- Ocular health within normal limits as determined by the investigator.
- No contact lens wear 14 days prior to enrollment and willing to not wear contact lenses for the duration of the study.
- Willing to follow a 14-day washout period due to contraindicated medication use, if deemed necessary by investigator.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Contraindications or hypersensitivity to the use of the test article or its components.
- Inability or unwillingness to follow all study instructions and complete study visits as required.
- Only one sighted eye or visual acuity not correctable to 20/30 (Snellen) in both eyes at the Screening Visit.
- Ocular trauma within 6 months prior to Visit 1 in either eye.
- Any ocular surgical intervention within six months prior to Visit 1 or anticipation of ocular surgery during the study.
- Presumed or actual ocular infection within 30 days prior to Visit 1.
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- Any severe or serious ocular condition or significant illness.
- Any abnormal slit-lamp findings at the time of the Screening Visit.
- Contact lens wear within 14 days prior to the study start and unwillingness to undergo a wash-out period of 14 days; unwilling to not wear contact lenses for the duration of the study.
- Use of over-the-counter (OTC) ocular medications within the past 14 days unless willing to follow wash out period.
- Use of topical or systemic ocular medications requiring longer than a two-week washout period.
- Participation in any other investigational study in the 30-day period before entry into this study (i.e., Visit 1) or concomitantly with this study.
- Women who are pregnant, nursing, or of childbearing potential not utilizing adequate birth control measures.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients Pre and Post Treatment With Olopatadine HCL Ophthalmic Solution, 0.2%
The purpose of this study is to descriptively evaluate the corneal structures of allergic conjunctivitis patients.
Read the detailed description
Heidelberg Retina Tomograph (HRT) will be used to descriptively evaluate the corneal structures and assess the immune cell status of allergic conjunctivitis patients pre- and post-treatment with olopatadine 0.2% in relation to a normative database.
- Conditions
- Allergic Conjunctivitis
- Being tested
- Olopatadine hydrochloride ophthalmic solution, 0.2%
- Keywords
- allergic conjunctivitis, Pataday, Olopatadine
- 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®
| Study group | Role | What they receive |
|---|---|---|
| Pataday | Experimental | Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days 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.
Patient-Assessed Ocular Itching
The patient rated the severity of ocular itching using a predetermined 0-4 scale, where 0=none and 4=severe itching with irresistible urge to rub. Each eye was rated separately. A 2-week washout period from prior allergy medication (if applicable) preceded the baseline assessment.
Measured: Baseline (Day 1), Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2013
- Study completionJul 2013
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Sindt, OD, FAAO, Principal investigator, University of IowaPam Kaur, MS PhD, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697969
- Sponsor's protocol ID
- M-12-047
- Status last verified
- Jul 2014
- First submitted
- 27 Sep 2012
- Last updated
- 18 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients Pre and Post Treatment With Olopatadine HCL Ophthalmic Solution, 0.2%
- ClinicalTrials.gov ID
- NCT01697969
- Acronym / sponsor ID
- M-12-047
- Conditions
- Allergic Conjunctivitis
- Keywords
- allergic conjunctivitis, Pataday, Olopatadine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Posted 18 Aug 2014
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 descriptively evaluate the corneal structures of allergic conjunctivitis patients.
Detailed description
Heidelberg Retina Tomograph (HRT) will be used to descriptively evaluate the corneal structures and assess the immune cell status of allergic conjunctivitis patients pre- and post-treatment with olopatadine 0.2% in relation to a normative database.
Study design
- 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%, 1 drop once daily in both eyes for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Read, sign, and date an Ethics Committee reviewed and approved informed consent form.
- Females of childbearing potential who:
- Able to read, understand and answer questions by investigator.
- Willing and able to attend all required study visits and follow directions as stipulated by the protocol and investigator.
- History of allergic conjunctivitis (within the past 12 months) and active signs and symptoms of ocular allergies for which treatment is necessary, in the opinion of the investigator.
Key exclusion criteria (14 listed)
- Contraindications or hypersensitivity to the use of the test article or its components.
- Inability or unwillingness to follow all study instructions and complete study visits as required.
- Only one sighted eye or visual acuity not correctable to 20/30 (Snellen) in both eyes at the Screening Visit.
- Ocular trauma within 6 months prior to Visit 1 in either eye.
- Any ocular surgical intervention within six months prior to Visit 1 or anticipation of ocular surgery during the study.
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 |
Primary outcome
Patient-Assessed Ocular Itching
Time frame: Baseline (Day 1), Day 14
The patient rated the severity of ocular itching using a predetermined 0-4 scale, where 0=none and 4=severe itching with irresistible urge to rub. Each eye was rated separately. A 2-week washout period from prior allergy medication (if applicable) preceded the baseline assessment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
- 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.
Christine Sindt, OD, FAAO principal investigator
University of Iowa
Pam Kaur, MS PhD 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, 0.2% in people with Allergic Conjunctivitis, run by Alcon Research at 1 site in United States.
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 13 inclusion and 14 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 Aug 2014. 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 United States. 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?
Yes. Results are posted in the registry (first posted 18 Aug 2014). 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?
Patient-Assessed Ocular Itching (time frame: Baseline (Day 1), Day 14). 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 Aug 2014.