Eye AllergiesNCT01450176
Comparing Patient Satisfaction With Pataday or Bepreve
A study testing Olopatadine hydrochloride 0.2% and Bepotastine besilate ophthalmic solution 1.5% in people with Eye Allergies, run by McCabe Vision Center at 1 site in United States.
Trial summary
The purpose of this study is to compare patient satisfaction with Pataday (Olopatadine hydrochloride 0.2%) one daily (QD) and Bepreve (Bepotastine besilate ophthalmic solution 1.5%) two times a day (BID). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Allergies
- What is being tested?
- Olopatadine hydrochloride 0.2% and Bepotastine besilate ophthalmic solution 1.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2011
- Phase
- Interventional
- 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
- Be male or female subjects of any racial/ethnic group.
- Be at least 18 years of age or older.
- Have a diagnosis of allergic conjunctivitis with active symptoms, with no concurrent ocular allergy associated conditions and no plans to have ocular surgery during study period.
- Willing and able to return for all required visits and follow instructions from investigator and staff.
- Able to self-administer test article (TA) or have a caregiver available to instill all doses of TA.
- If a woman, capable of becoming pregnant, agrees to have pregnancy testing performed at screening (must be negative) and agrees to use a medically acceptable form of birth control (intrauterine device, birth control pill, patch or subcutaneous implant, condoms, diaphragm, and abstinence) throughout the study duration and for at least one week prior to and one week after completion of the study. Women considered capable of becoming pregnant include all females who have experienced menarche and who have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).
- Sign and date the informed consent form approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
- Be willing/able to return for all required study visits, to follow instructions from the study investigator and his/her staff, and to complete and return the Screening and Subject Diaries.
Who cannot join
- Have known hypersensitivity to BEPREVE or PATADAY or any of their components.
- Are actively taking steroids or antihistamines during the study or within 7 days prior to enrolling in the study.
- Are pregnant, planning to become pregnant, or nursing/lactating.
- Have a known history of alcohol or drug abuse.
- Participated in a study of an investigational drug or device within the past 30 days prior to enrolling in the study.
- Have a presence of an active ocular infection (bacterial, viral or fungal), positive history of an ocular herpetic infection, or preauricular lymphadenopathy at any visit.
- Have any significant illness {eg: any autoimmune disease, or severe cardiovascular disease (including arrhythmias)}that the Investigator feels could be expected to interfere with the subject's safety or study parameters and/or put the subject at anyh unnecessary risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Patient Satisfaction Throughout the Day With PATADAY (OLOPATADINE HYDROCHLORIDE) 0.2% QD or BEPREVE (BEPOTASTINE BESILATE OPHTHALMIC SOLUTION) 1.5% BID
The purpose of this study is to compare patient satisfaction with Pataday (Olopatadine hydrochloride 0.2%) one daily (QD) and Bepreve (Bepotastine besilate ophthalmic solution 1.5%) two times a day (BID).
Read the detailed description
5 week randomized study with 15 subjects using Pataday qd for 2 weeks, and the other 15 subjects using Bepreve BID for 2 weeks. Following a one-week washout period, the two groups are given the opposite test article (TA) for 2 weeks. Subjects to complete daily diary regarding effects of drug and are seen in clinic for 3 exams.
- Conditions
- Eye Allergies
- Being tested
- Olopatadine hydrochloride 0.2%, Bepotastine besilate ophthalmic solution 1.5%
- Keywords
- eye, itching, allergies
- Medical subject headings
- Pruritus, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olopatadine hydrochloride 0.2%Drug
Also called Pataday
1 drop in each eye once daily for 2 weeks
Bepotastine besilate ophthalmic solution 1.5%Drug
Also called Bepreve
1 drop in each eye twice daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pataday once daily | Active comparator | 15 subjects will administer Pataday once daily for 2 weeks. Then these subjects will administer Bepreve twice daily for 2 weeks. Receives: Drug: Olopatadine hydrochloride 0.2% |
| Bepreve twice daily | Active comparator | Bepreve twice daily for 2 weeks, then subjects will use Pataday once daily for 2 weeks Receives: Drug: Bepotastine besilate ophthalmic solution 1.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of ocular itching
All day relief of ocular itching throughout the treatment period.
Measured: 5 weeks
Secondary outcomes (1)
Patient preference
Patient satisfaction, preference, and comfort with treatment
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionOct 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 Eye AllergiesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- McCabe Vision Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450176
- Sponsor's protocol ID
- MAC-04-11
- Other IDs
- 3776-001
- Status last verified
- Jan 2014
- First submitted
- 7 Oct 2011
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Patient Satisfaction Throughout the Day With PATADAY (OLOPATADINE HYDROCHLORIDE) 0.2% QD or BEPREVE (BEPOTASTINE BESILATE OPHTHALMIC SOLUTION) 1.5% BID
- ClinicalTrials.gov ID
- NCT01450176
- Acronym / sponsor ID
- MAC-04-11
- Conditions
- Eye Allergies
- Keywords
- eye, itching, allergies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- McCabe Vision CenterUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Oct 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 is to compare patient satisfaction with Pataday (Olopatadine hydrochloride 0.2%) one daily (QD) and Bepreve (Bepotastine besilate ophthalmic solution 1.5%) two times a day (BID).
Detailed description
5 week randomized study with 15 subjects using Pataday qd for 2 weeks, and the other 15 subjects using Bepreve BID for 2 weeks. Following a one-week washout period, the two groups are given the opposite test article (TA) for 2 weeks. Subjects to complete daily diary regarding effects of drug and are seen in clinic for 3 exams.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pataday once daily | Active comparator | Drug: Olopatadine hydrochloride 0.2%15 subjects will administer Pataday once daily for 2 weeks. Then these subjects will administer Bepreve twice daily for 2 weeks. |
| Bepreve twice daily | Active comparator | Drug: Bepotastine besilate ophthalmic solution 1.5%Bepreve twice daily for 2 weeks, then subjects will use Pataday once daily for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be male or female subjects of any racial/ethnic group.
- Be at least 18 years of age or older.
- Have a diagnosis of allergic conjunctivitis with active symptoms, with no concurrent ocular allergy associated conditions and no plans to have ocular surgery during study period.
- Willing and able to return for all required visits and follow instructions from investigator and staff.
- Able to self-administer test article (TA) or have a caregiver available to instill all doses of TA.
Key exclusion criteria (7 listed)
- Have known hypersensitivity to BEPREVE or PATADAY or any of their components.
- Are actively taking steroids or antihistamines during the study or within 7 days prior to enrolling in the study.
- Are pregnant, planning to become pregnant, or nursing/lactating.
- Have a known history of alcohol or drug abuse.
- Participated in a study of an investigational drug or device within the past 30 days prior to enrolling in 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 0.2%Also: Pataday1 drop in each eye once daily for 2 weeks | Drug | Pataday once daily |
| Bepotastine besilate ophthalmic solution 1.5%Also: Bepreve1 drop in each eye twice daily for 2 weeks | Drug | Bepreve twice daily |
Primary outcome
Relief of ocular itching
Time frame: 5 weeks
All day relief of ocular itching throughout the treatment period.
1 secondary outcome
Patient preference
Time frame: 5 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 9 Jan 2014.
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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 study testing Olopatadine hydrochloride 0.2% and Bepotastine besilate ophthalmic solution 1.5% in people with Eye Allergies, run by McCabe Vision Center 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 8 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 9 Jan 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.
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?
Relief of ocular itching (time frame: 5 weeks). 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 9 Jan 2014; AzTrials last refreshed its copy on 4 Nov 2026.