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To assess the comfort preference of ISTA Tears vs Systane in patients with dry eye disease (DED)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISTA Tears | Experimental | Sterile ophthalmic solution |
|
| Systane | Active Comparator | Sterile ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISTA Tears | Drug | sterile ophthalmic solution |
| |
| Systane |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Preference for One of the Treatments | There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total). Participants were asked to indicate which treatment they preferred, or if they preferred neither. | 30 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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There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total).
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Each participant has 2 eyes. There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total). The protocol required that participants be least 18 years of age, male or female. Participant demographic information was not collected.
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants Received Both ISTA Tears and Systane | ISTA Tears: sterile ophthalmic solution used in the right eye. Systane: Sterile ophthalmic solution used in the left eye. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Percentage of Participants With Preference for One of the Treatments | There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total). Participants were asked to indicate which treatment they preferred, or if they preferred neither. | There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total). | Posted | Count of Participants | Participants | 30 days |
|
|
30 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 | Participants Received Both ISTA Tears and Systane | ISTA Tears: sterile ophthalmic solution used in the right eye. Systane: Sterile ophthalmic solution used in the left eye. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | 908-300-9920 | 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 |
|
| Eyes |
|
| Participants |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | Participants |
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
Contact sponsor directly for detail.