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| Name | Class |
|---|---|
| Bausch & Lomb Incorporated | INDUSTRY |
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The purpose of this study is to compare the effect of Bepreve® with an artificial-tear eye drop on the quality of your tears.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refresh Tears® eye drops | Placebo Comparator | Must add drops twice a day every day during trial enrollment. |
|
| Bepreve® 1.5% solution | Experimental | Must add drops twice a day every day while enrolled in trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Refresh Tears 0.5% Lubricant Eye Drops | Drug |
| ||
| Bepreve 1.5% Ophthalmic Solution |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Osmolarity | The TearLab Osmolarity System will be used to assess tear film osmolarity, measured in mOsms/L. | 56 days after initial screening visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmad M Fahmy, O.D. | Minnesota Eye Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minnesota Eye Consultants, P.A. | Minneapolis | Minnesota | 55404 | United States |
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| Label | URL |
|---|---|
| Minnesota Eye Consultants | View source |
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Recruitment began Aug 15, 2011 and concluded June 11, 2012. There are a variety of sources we recruited our subjects from which is outlined below:
Email. PI referrals, employee, and subject referrals. Flyers posted around college campuses. Website clinicaltrial.gov.
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| ID | Title | Description |
|---|---|---|
| FG000 | Refresh Tears® Eye Drops | Must add drops twice a day every day during trial enrollment. |
| FG001 | Bepreve® 1.5% Solution | Must add drops twice a day every day while enrolled in trial. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Refresh Tears® Eye Drops | Must add drops twice a day every day during trial enrollment. |
| BG001 | Bepreve® 1.5% Solution | Must add drops twice a day every day while enrolled in trial. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tear Osmolarity | The TearLab Osmolarity System will be used to assess tear film osmolarity, measured in mOsms/L. | Analysis per protocol as ITT and LOCF for all subject eyes. | Posted | Mean | Standard Deviation | mOsM/L | 56 days after initial screening visit | Eyes | Eyes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Refresh Tears® Eye Drops | Must add drops twice a day every day during trial enrollment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular Irritation | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ahmad Fahmy, OD | Minnesota Eye Consultants, P.A. | 612-813-3665 | amfahmy@mneye.com |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| D003231 | Conjunctivitis |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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| ID | Term |
|---|---|
| D065346 | Lubricant Eye Drops |
| C511534 | bepotastine besilate |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
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| Drug |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
| Eyes |
|
|
| 0 |
| 20 |
| 10 |
| 20 |
| EG001 | Bepreve® 1.5% Solution | Must add drops twice a day every day while enrolled in trial. | 0 | 20 | 14 | 20 |
| Ocular Burning | Eye disorders | Systematic Assessment |
|
| Ocular itching | Eye disorders | Systematic Assessment |
|
| Cold like symptoms | General disorders | Non-systematic Assessment |
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| Stomach problems | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bad Taste in mouth | General disorders | Non-systematic Assessment |
|
| General eye discomfort | Eye disorders | Systematic Assessment |
|
| Joint/muscle pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D007154 |
| Immune System Diseases |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |