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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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Research indicates that many people who are being treated for glaucoma have dry eyes. The purpose of this study is to test the use of artificial tears to alleviate dryness signs and symptoms in people who are using medication to treat glaucoma. The study hypothesis is that the use of artificial tears will result in an improvement in clinical signs and symptoms associated with dry eyes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refresh Tears Lubricant Eye Drops (Allergan) | Experimental | Artificial tears eye drops QID for 1 month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Refresh Tears Lubricant Eye Drops (Allergan) | Drug | Eye drops QID for 1 month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Staining | Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence | At baseline (dispensing visit) |
| Ocular Surface Staining | Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence | After 1 week |
| Ocular Surface Staining | Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence | After 1 month |
| Tear Break up Time With Fluorescein | The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation . | At baseline (dispensing visit) |
| Tear Break up Time With Fluorescein | The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation . | After 1 week |
| Tear Break up Time With Fluorescein | The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation . | After 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Disease Index (OSDI) Score | The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score). |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Ratings of Comfort | Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort) | At baseline (dispensing visit) |
| Subjective Ratings of Comfort |
Inclusion Criteria:
Exclusion Criteria:
Is participating in any concurrent clinical or research study;
Has any known active* ocular disease and/or infection; except primary open angle glaucoma.
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications (with the exception of glaucoma medication) that in the opinion of the investigator may affect a study outcome variable;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Is pregnant, lactating or planning a pregnancy at the time of enrolment;
Has undergone refractive error surgery;
Is an employee of the Centre for Contact Lens Research;
Has taken part in another (pharmaceutical) research study within the last 30 days;
Is currently using artificial tears more than 3 times per day.
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones, PhD | University of Waterloo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Contact Lens Research, University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Refresh Tears Lubricant Eye Drops (Allergan) | Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Refresh Tears Lubricant Eye Drops (Allergan) | Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Ocular Surface Staining | Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence | Posted | Mean | Standard Deviation | units on a scale | At baseline (dispensing visit) |
|
|
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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 Lubricant Eye Drops (Allergan) | Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal marginal keratitis | Eye disorders | Unrelated to study drops |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Manager | CCLR | 519-888-4742 | cclr2@sciborg.uwaterloo.ca |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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| At baseline (dispensing visit) |
| Ocular Surface Disease Index (OSDI) Score | The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score). | 1 week after using artificial tears |
| Ocular Surface Disease Index (OSDI) Score | The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worse possible score). | 1 month after using artificial tears |
Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort)
| 1 week after using artificial tears |
| Subjective Ratings of Comfort | Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort) | 1 month after using artificial tears |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Ocular Surface Staining | Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence | Posted | Mean | Standard Deviation | units on a scale | After 1 week |
|
|
|
| Primary | Ocular Surface Staining | Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence | Posted | Mean | Standard Deviation | units on a scale | After 1 month |
|
|
|
| Primary | Tear Break up Time With Fluorescein | The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation . | Posted | Mean | Standard Deviation | seconds | At baseline (dispensing visit) |
|
|
|
| Primary | Tear Break up Time With Fluorescein | The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation . | Posted | Mean | Standard Deviation | seconds | After 1 week |
|
|
|
| Primary | Tear Break up Time With Fluorescein | The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation . | Posted | Mean | Standard Deviation | seconds | After 1 month |
|
|
|
| Secondary | Ocular Surface Disease Index (OSDI) Score | The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score). | Posted | Mean | Standard Deviation | units on a scale | At baseline (dispensing visit) |
|
|
|
| Other Pre-specified | Subjective Ratings of Comfort | Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort) | Posted | Mean | Standard Deviation | units on a scale | At baseline (dispensing visit) |
|
|
|
| Secondary | Ocular Surface Disease Index (OSDI) Score | The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score). | Posted | Mean | Standard Deviation | units on a scale | 1 week after using artificial tears |
|
|
|
| Secondary | Ocular Surface Disease Index (OSDI) Score | The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worse possible score). | Posted | Mean | Standard Deviation | units on a scale | 1 month after using artificial tears |
|
|
|
| Other Pre-specified | Subjective Ratings of Comfort | Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort) | Posted | Mean | Standard Deviation | units on a scale | 1 week after using artificial tears |
|
|
|
| Other Pre-specified | Subjective Ratings of Comfort | Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort) | Posted | Mean | Standard Deviation | units on a scale | 1 month after using artificial tears |
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| 0 |
| 11 |
| 1 |
| 11 |
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