Allergic ConjunctivitisPhase 4NCT01346371
The Effect of BEPREVE 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer
A Phase 4 study testing Refresh Tears 0.5% Lubricant Eye Drops and Bepreve 1.5% Ophthalmic Solution in people with Allergic Conjunctivitis, run by Minnesota Eye Consultants, P.A. at 1 site in United States.
Trial summary
The purpose of this study is to compare the effect of Bepreve® with an artificial-tear eye drop on the quality of your tears. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- Refresh Tears 0.5% Lubricant Eye Drops and Bepreve 1.5% Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Sep 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are male or female at least 18 years of age who are diagnosed with allergic conjunctivitis.
- Have documented positive skin prick puncture test to at least one (1) seasonal allergen (e.g., grasses, trees, weeds, or other allergens) within two (2) years of Visit 1.
- Agree not to have any other ocular drops in study eyes within 2 days prior to the initiation of dosing with the test article or throughout the duration of the study.
- Have a Best Corrected Visual Acuity of 20/200 or better in either eye.
- Are willing/able to follow instructions from the study investigator and his/her staff.
- Be willing/able to return for all required study visits, to follow instructions from the study investigator and his/her staff.
- Are able to self-administer test article (or have a caregiver available to instill all doses of test article).
- Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.
Who cannot join
- Have known hypersensitivity to either BEPREVE™ or REFRESH TEARS® or to any component of the test article (including "procedural" medications such as anesthetic and/or fluorescein drops, dilating drops, etc.).
- Have active corneal pathology noted in the study eye at the screening visit. Active corneal pathology is defined as corneal pathology that is non-stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment.
- Have used topical, ocular, inhaled or systemic steroids within 14 days prior to screening.
- Have a history of abuse of alcohol/drugs within six months prior to the screening visit.
- Are pregnant or nursing/lactating.
- Have participated in any other study of an investigational drug or device within 30 days prior to randomization.
Trial locations and contacts
1 site in 1 country.
United States1 site
Minnesota Eye Consultants, P.A.
Minneapolis, Minnesota, 55404
About this study
Official title: The Effect of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer
The purpose of this study is to compare the effect of Bepreve® with an artificial-tear eye drop on the quality of your tears.
Read the detailed description
This is a single-center, randomized, parallel group, placebo-controlled study to evaluate the effect of BEPREVE compared to a placebo eye drop on the measurement of tear film osmolarity and tear film lipid layer in patients with allergic conjunctivitis.
Subjects will be screened for this study on day one of dosing with the test article. Subjects who sign the informed consent form and who meet all inclusion/exclusion criteria will be eligible for participation in this study. They will be assigned sequentially, according to a computer generated randomization list, in a ratio of 1:1 to receive either BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5% or REFRESH TEARS® Lubricant Eye Drops (1:1). Subjects will instill one drop of test article either BEPREVE™ or REFRESH TEARS® into the study eyes twice daily for a maximum of 60 days. Subjects will be seen for evaluation on Days 0, 28±3, and 56±3 following randomization.
- Conditions
- Allergic Conjunctivitis
- Being tested
- Refresh Tears 0.5% Lubricant Eye Drops, Bepreve 1.5% Ophthalmic Solution
- Keywords
- Allergic, conjunctivitis, Allergic 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.
Refresh Tears 0.5% Lubricant Eye DropsDrug
Bepreve 1.5% Ophthalmic SolutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Refresh Tears® eye drops | Placebo comparator | Must add drops twice a day every day during trial enrollment. Receives: Drug: Bepreve 1.5% Ophthalmic Solution |
| Bepreve® 1.5% solution | Experimental | Must add drops twice a day every day while enrolled in trial. Receives: Drug: Refresh Tears 0.5% Lubricant Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Osmolarity
The TearLab Osmolarity System will be used to assess tear film osmolarity, measured in mOsms/L.
Measured: 56 days after initial screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2012
- Study completionSep 2012
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.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minnesota Eye Consultants, P.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Sponsor
- Investigators
- Ahmad M Fahmy, O.D., Principal investigator, Minnesota Eye Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346371
- Sponsor's protocol ID
- MAC-01-11
- Status last verified
- Mar 2020
- First submitted
- 29 Apr 2011
- Last updated
- 31 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer
- ClinicalTrials.gov ID
- NCT01346371
- Acronym / sponsor ID
- MAC-01-11
- Conditions
- Allergic Conjunctivitis
- Keywords
- Allergic, conjunctivitis, Allergic conjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Minnesota Eye Consultants, P.A.Industry (pharma, biotech, devices)
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- May 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 3 May 2011 (estimated)
- Results
- Posted 31 Mar 2020
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 the effect of Bepreve® with an artificial-tear eye drop on the quality of your tears.
Detailed description
This is a single-center, randomized, parallel group, placebo-controlled study to evaluate the effect of BEPREVE compared to a placebo eye drop on the measurement of tear film osmolarity and tear film lipid layer in patients with allergic conjunctivitis.
Subjects will be screened for this study on day one of dosing with the test article. Subjects who sign the informed consent form and who meet all inclusion/exclusion criteria will be eligible for participation in this study. They will be assigned sequentially, according to a computer generated randomization list, in a ratio of 1:1 to receive either BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5% or REFRESH TEARS® Lubricant Eye Drops (1:1). Subjects will instill one drop of test article either BEPREVE™ or REFRESH TEARS® into the study eyes twice daily for a maximum of 60 days. Subjects will be seen for evaluation on Days 0, 28±3, and 56±3 following randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Refresh Tears® eye drops | Placebo comparator | Drug: Bepreve 1.5% Ophthalmic SolutionMust add drops twice a day every day during trial enrollment. |
| Bepreve® 1.5% solution | Experimental | Drug: Refresh Tears 0.5% Lubricant Eye DropsMust add drops twice a day every day while enrolled in trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Are male or female at least 18 years of age who are diagnosed with allergic conjunctivitis.
- Have documented positive skin prick puncture test to at least one (1) seasonal allergen (e.g., grasses, trees, weeds, or other allergens) within two (2) years of Visit 1.
- Agree not to have any other ocular drops in study eyes within 2 days prior to the initiation of dosing with the test article or throughout the duration of the study.
- Have a Best Corrected Visual Acuity of 20/200 or better in either eye.
- Are willing/able to follow instructions from the study investigator and his/her staff.
Key exclusion criteria (6 listed)
- Have known hypersensitivity to either BEPREVE™ or REFRESH TEARS® or to any component of the test article (including "procedural" medications such as anesthetic and/or fluorescein drops, dilating drops, etc.).
- Have active corneal pathology noted in the study eye at the screening visit. Active corneal pathology is defined as corneal pathology that is non-stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment.
- Have used topical, ocular, inhaled or systemic steroids within 14 days prior to screening.
- Have a history of abuse of alcohol/drugs within six months prior to the screening visit.
- Are pregnant or nursing/lactating.
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 |
|---|---|---|
| Refresh Tears 0.5% Lubricant Eye Drops | Drug | Bepreve® 1.5% solution |
| Bepreve 1.5% Ophthalmic Solution | Drug | Refresh Tears® eye drops |
Primary outcome
Tear Osmolarity
Time frame: 56 days after initial screening visit
The TearLab Osmolarity System will be used to assess tear film osmolarity, measured in mOsms/L.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Minnesota Eye ConsultantsLink provided by the sponsor.
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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.
Ahmad M Fahmy, O.D. principal investigator
Minnesota Eye Consultants
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 Refresh Tears 0.5% Lubricant Eye Drops and Bepreve 1.5% Ophthalmic Solution in people with Allergic Conjunctivitis, run by Minnesota Eye Consultants, P.A. 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 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 31 Mar 2020. 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. 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 31 Mar 2020). 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?
Tear Osmolarity (time frame: 56 days after initial screening visit). 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 31 Mar 2020.