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The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Carboxymethylcellulose and Glycerin based artificial tear |
|
| 2 | Active Comparator | Carboxymethylcellulose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin based artificial tear | Drug | 1 to 2 drops into each eye as needed but at least twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score | Ocular Surface Disease Index© Questionnaire Score is measured on 12 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity) | Change from baseline at Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Day 30 in Schirmer Test, With Anesthesia | Schirmer Test measures the rate of the secretion of tears | Change from baseline at Day 30 |
| Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein |
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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 |
|---|---|---|---|---|---|---|
| San Diego | California | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Carboxymethylcellulose and Glycerin Based Artificial Tear | 1 to 2 drops into each eye as needed but at least twice daily |
| FG001 | Carboxymethylcellulose Based Artificial Tear | 1 to 2 drops into each eye as needed but at least twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Carboxymethylcellulose and Glycerin Based Artificial Tear | 1 to 2 drops into each eye as needed but at least twice daily |
| BG001 | Carboxymethylcellulose Based Artificial Tear | 1 to 2 drops into each eye as needed but at least twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score | Ocular Surface Disease Index© Questionnaire Score is measured on 12 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity) | Intent to Treat Population (Modified) | Posted | Mean | Standard Deviation | Units on a scale | Change from baseline at Day 30 |
|
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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 Based Artificial Tear | 1 to 2 drops into each eye as needed but at least twice daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient Ischaemic Attack | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | 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 |
|---|---|
| D002266 | Carboxymethylcellulose Sodium |
| ID | Term |
|---|---|
| D008747 | Methylcellulose |
| D002482 | Cellulose |
| D005936 | Glucans |
| D011134 | Polysaccharides |
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| Carboxymethylcellulose | Drug | 1 to 2 drops into each eye as needed but at least twice daily |
|
|
Measures the stability of tear film. The average of 3 measures.
| Change from baseline at Day 30 |
| Patient Acceptability Score (Dryness) at Day 30 | Dryness Severity Visual Analog Scale is measured on a 0-100 point scale (0 = could not be worse, 100 = none at all). | Day 30 |
| Patient Acceptability Score (Vision) at Day 30 | Vision Quality Visual Analog Scale is measured on a 0-100 point scale (0 = very poor, has never been worse, 100 = excellent, has never been better). | Day 30 |
| Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein | Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-25 (0= no staining, 25 = most severe staining) | Change from baseline at Day 30 |
| Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein | Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-30 (0=no staining, 30=most severe staining) | Change from baseline at Day 30 |
| Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score | Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe) | Change from baseline at Day 30 |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Change From Baseline at Day 30 in Schirmer Test, With Anesthesia | Schirmer Test measures the rate of the secretion of tears | Intent to Treat Population | Posted | Mean | Standard Deviation | mm/5min | Change from baseline at Day 30 |
|
|
|
| Secondary | Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein | Measures the stability of tear film. The average of 3 measures. | Intent to Treat Population | Posted | Mean | Standard Deviation | seconds | Change from baseline at Day 30 |
|
|
|
| Secondary | Patient Acceptability Score (Dryness) at Day 30 | Dryness Severity Visual Analog Scale is measured on a 0-100 point scale (0 = could not be worse, 100 = none at all). | Intent to Treat Population | Posted | Mean | Standard Deviation | Units on scale | Day 30 |
|
|
|
| Secondary | Patient Acceptability Score (Vision) at Day 30 | Vision Quality Visual Analog Scale is measured on a 0-100 point scale (0 = very poor, has never been worse, 100 = excellent, has never been better). | Intent to treat population | Posted | Mean | Standard Deviation | Units on a scale | Day 30 |
|
|
|
| Post-Hoc | Vision Subscale of the Ocular Surface Disease Index Questionnaire© at Day 30 | Vision subscale of the Ocular Surface Disease Index Questionnaire© is measured on 6 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity) | Intent to Treat Population (Modified) | Posted | Mean | Standard Deviation | Units on a scale | Day 30 |
|
|
|
| Post-Hoc | Ocular Surface Staining With Fluorescein (Central Cornea) at Day 30 | Central staining score is based on modified Oxford Scheme measured on a scale of 0-5 (0= no staining, 5= most severe staining) | Intent to Treat Population | Posted | Mean | Standard Deviation | Units on a scale | Day 30 |
|
|
|
| Secondary | Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein | Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-25 (0= no staining, 25 = most severe staining) | Intent to Treat Population | Posted | Mean | Standard Deviation | Units on a scale | Change from baseline at Day 30 |
|
|
|
| Secondary | Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein | Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-30 (0=no staining, 30=most severe staining) | Intent to Treat Population | Posted | Mean | Standard Deviation | Units on a scale | Change from baseline at Day 30 |
|
|
|
| Secondary | Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score | Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe) | Intent to Treat Population | Posted | Mean | Standard Deviation | Units on a scale | Change from baseline at Day 30 |
|
|
|
| 1 |
| 157 |
| 0 |
| 157 |
| EG001 | Carboxymethylcellulose Based Artificial Tear | 1 to 2 drops into each eye as needed but at least twice daily | 1 | 159 | 0 | 159 |
| Menorrhagia | Reproductive system and breast disorders | Non-systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D002241 |
| Carbohydrates |
| Day 30 |
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| Day 30 |
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| Day 30 |
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| Day 30 |
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