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This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when administered for one month to patients with mild to moderate dry eye symptoms, with and without contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Optive Eyedrops |
|
| 2 | Active Comparator | Hylocomod Eyedrops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE® | Drug | Eyedrops as required, but at least 3 times per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival Staining by Lissamine Green | Percentage of cases of limbal staining by lissamine green at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe) | week 1, month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Staining by Fluorescein | Percentage of cases of limbal staining by sodium fluorescein at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe) | week 1, month 1 |
| Conjunctival Hyperaemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London | London | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Carboxymethylcellulose and Glycerin | |
| FG001 | Sodium Hyaluronate |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Carboxymethylcellulose and Glycerin | |
| BG001 | Sodium Hyaluronate | |
| BG002 | Total |
| 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 | Conjunctival Staining by Lissamine Green | Percentage of cases of limbal staining by lissamine green at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe) | Intent to Treat Population | Posted | Number | Percentage of Participants | week 1, month 1 |
|
|
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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 | Carboxymethylcellulose and Glycerin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Lid Cyst | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs - Europe | Allergan, Inc. | (714)246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005990 | Glycerol |
| D011309 | Preservation, Biological |
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Sodium hyaluronate | Drug | Eyedrops as required, but at least 3 times per day |
|
|
Percentage of conjunctival response reported in terms of limbal hyperaemia for the worst responses over the area at each point on a five point scale (0=clear/white conjunctiva, 1=slight redness, 2=Mild redness, 3=Moderate redness, 4=Severe redness)
| week 1, month 1 |
| Ocular Comfort and Ocular Symptoms on Visual Analogue Scale | Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent) | week 1, month 1 |
| Daily Eyedrop Usage | Average daily eyedrop use | Month 1 |
| Lipid Layer Pattern Assessment | Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer. | Week 1, month 1 |
Total of all reporting groups
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Corneal Staining by Fluorescein | Percentage of cases of limbal staining by sodium fluorescein at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe) | Intent to Treat Population | Posted | Number | Percentage of Participants | week 1, month 1 |
|
|
|
| Secondary | Conjunctival Hyperaemia | Percentage of conjunctival response reported in terms of limbal hyperaemia for the worst responses over the area at each point on a five point scale (0=clear/white conjunctiva, 1=slight redness, 2=Mild redness, 3=Moderate redness, 4=Severe redness) | Intent to Treat Population | Posted | Number | Percentage of Participants | week 1, month 1 |
|
|
|
| Secondary | Ocular Comfort and Ocular Symptoms on Visual Analogue Scale | Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent) | Intent to Treat Population | Posted | Mean | Standard Deviation | Units on a scale | week 1, month 1 |
|
|
|
| Secondary | Daily Eyedrop Usage | Average daily eyedrop use | Intent to Treat Population | Posted | Mean | Standard Deviation | drops/day | Month 1 |
|
|
|
| Secondary | Lipid Layer Pattern Assessment | Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer. | Intent to Treat Population | Posted | Median | Full Range | Lipid Layer Mixing Pattern | Week 1, month 1 |
|
|
|
| 0 |
| 21 |
| 2 |
| 21 |
| EG001 | Sodium Hyaluronate | 0 | 26 | 2 | 26 |
| Mild Corneal Toxicity | Eye disorders | Systematic Assessment |
|
| Foot Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| D002241 |
| Carbohydrates |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| Week 1 - Mild |
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| Week 1 - Moderate |
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| Week 1 - Severe |
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| Month 1 - None |
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| Month 1 - Trace |
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| Month 1 - Mild |
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| Month 1 - Moderate |
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| Month 1 - Severe |
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| Week 1 - Mild |
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| Week 1 - Moderate |
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| Week 1 - Severe |
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| Month 1 - Clear/White |
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| Month 1 - Slight |
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| Month 1 - Mild |
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| Month 1 - Moderate |
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| Month 1 - Severe |
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| Ocular Comfort - Evening (Wk.1) |
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| Ocular Comfort - Waking (Mo.1) |
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| Ocular Comfort - Daytime (Mo.1) |
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| Ocular Comfort - Evening (Mo.1) |
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