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Efficacy study of ecabet ophthalmic solution in dry eye disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ecabet ophthalmic solution |
|
| 2 | Placebo Comparator | Placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ecabet ophthalmic solution | Drug | sterile ophthalmic solution |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Lacrimation Assessed by Schirmer's Test | The Schirmer's test is used determine if tear glands produce enough tears to keep eyes adequately moist. Calibrated strips of a non-toxic filter paper are used. One free end is placed within the lower eyelid. At the conclusion of the test, the paper strip is removed from the lower eyelid and the amount of wetting of the paper strip is measured. | 43 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim McNamara, PharmD | ISTA Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISTA Pharmaceuticals, Inc. | Irvine | California | 92618 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ecabet Ophthalmic Solution | ecabet ophthalmic solution ecabet ophthalmic solution: sterile ophthalmic solution |
| FG001 | Vehicle | Placebo comparator placebo: sterile ophthalmic solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ecabet Ophthalmic Solution | ecabet ophthalmic solution ecabet ophthalmic solution: sterile ophthalmic solution |
| BG001 | Vehicle | Placebo comparator placebo: sterile ophthalmic solution |
| 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 | Mean Change From Baseline in Lacrimation Assessed by Schirmer's Test | The Schirmer's test is used determine if tear glands produce enough tears to keep eyes adequately moist. Calibrated strips of a non-toxic filter paper are used. One free end is placed within the lower eyelid. At the conclusion of the test, the paper strip is removed from the lower eyelid and the amount of wetting of the paper strip is measured. | Posted | Mean | Standard Deviation | mm | 43 days |
|
43 days
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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 | Ecabet Ophthalmic Solution | ecabet ophthalmic solution ecabet ophthalmic solution: sterile ophthalmic solution |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | susan.harris@bauschhealth.com |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Drug |
sterile ophthalmic solution |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 1 |
| 95 |
| 0 |
| 95 |
| EG001 | Vehicle | Placebo comparator placebo: sterile ophthalmic solution | 0 | 88 | 0 | 88 |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
Contact sponsor directly for details.