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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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Systane Ultra is at least as efficacious and safe as Refresh Tears in Asian people with Dry Eyes
Comparison of efficacy of Systane Ultra and Refresh Tears
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systane Ultra | Experimental | Used four times a day topically to each eye |
|
| Refresh | Active Comparator | Used four times a day topically to each eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systane Ultra eyedrops | Drug | Four times a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Score (VAS) | Global score calculated from square root( square of (discomfort severityX Sqr(symptom frequency)) Scale from 0 to 100 higher value indicates more adverse symptoms each subscale severity or frequency also has same minimum and maximum | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Fluorescein Staining Score | This is graded in the 5 zones of each cornea according to number of spots of corneal fluorescein staining, confluency of spots and presence of filaments if any | 6 weeks |
| Tear Break Up Time (TBUT) |
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Inclusion Criteria:
Subject age is between 40 and 65 years old.
Corneal fluorescein staining present in at least one/five sectors of at least one cornea
At least one question out of 6 questions on dry eye symptom present often or all the time.
based on the Salisbury Eye study by Oliver Schein et al. (Does your eye feel dry, gritty, red, watery, crusted, stuck in the morning?) Please see appendix 1.
At least one of the following: TBUT <= 5 s or Schirmer I less than 8 mm in at least one eye
Yamaguchi score 2 in at least one sector of one of 4 lids (slight advancement of Marx's line in line with Meibomian orifice)
Not using non-lubricant ophthalmic drops within the last 30 days and able to abstain from non-trial topical eye medications for 6 weeks.
Use of lubricants during the week before recruitment (ranging from 3 times in the week to less than 6 times a day every day).
Able to use saline eyedrops during the 7 day 'washout' evaluative phase, between 3 times over week to less than 6 times a day in all days.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis Tong, FRCS, MD | Singapore National Eye Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore National Eye Center | Singapore | 168751 | Singapore |
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| ID | Title | Description |
|---|---|---|
| FG000 | Systane Ultra | four times a day for six weeks in each eye |
| FG001 | Refresh | Four times a day for 6 weeks in each eye |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Systane Ultra | four times a day for six weeks in each eye |
| BG001 | Refresh | Four times a day for 6 weeks in each eye |
| 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 | Visual Analog Score (VAS) | Global score calculated from square root( square of (discomfort severityX Sqr(symptom frequency)) Scale from 0 to 100 higher value indicates more adverse symptoms each subscale severity or frequency also has same minimum and maximum | intention to treat | Posted | Mean | Standard Deviation | scores on a scale | 6 weeks |
|
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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 | Systane Ultra | four times a day for six weeks in each eye |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Louis Tong | Singapore National Eye Center | 65 62277255 | Louis.tong.h.t@snec.com.sg |
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| ID | Term |
|---|---|
| D014985 | Xerophthalmia |
| D001762 | Blepharitis |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
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| ID | Term |
|---|---|
| C022030 | methylacetylene |
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| Refresh eye drops | Drug | Four times a day |
|
|
| 6 weeks |
| Schirmer I Reading | 6 weeks |
| Meibography Grading | 6 weeks |
| Tear Osmolarity | This is measured by the TearLab (Ocusense) system | 6 weeks |
| Superior and Inferior Tear Meniscus Height | This is determined by anterior segment OCT visante system | 6 weeks |
| 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Corneal Fluorescein Staining Score | This is graded in the 5 zones of each cornea according to number of spots of corneal fluorescein staining, confluency of spots and presence of filaments if any | Not Posted | Mean | Standard Deviation | staining grade | 6 weeks |
| Secondary | Tear Break Up Time (TBUT) | Not Posted | Mean | Standard Deviation | seconds | 6 weeks |
| Secondary | Schirmer I Reading | Not Posted | Mean | Standard Deviation | mm | 6 weeks |
| Secondary | Meibography Grading | Not Posted | Mean | Standard Deviation | arbitrary grade | 6 weeks |
| Secondary | Tear Osmolarity | This is measured by the TearLab (Ocusense) system | Not Posted | Mean | Standard Deviation | mOsM | 6 weeks |
| Secondary | Superior and Inferior Tear Meniscus Height | This is determined by anterior segment OCT visante system | Not Posted | Mean | Standard Deviation | mm | 6 weeks |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Refresh | Four times a day for 6 weeks in each eye | 0 | 15 | 0 | 15 |
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| D005141 |
| Eyelid Diseases |