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This is an observational study of OPTIVE PLUS® in patients with dry eye disease in a routine clinical setting. Treatment decisions are made by the physician and reflect the physician's current standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPTIVE PLUS® | Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPTIVE PLUS® | Drug | Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS® | Patients rated their satisfaction with OPTIVE PLUS® as treatment for dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied). | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS® | The physician rated their satisfaction with OPTIVE PLUS® for the treatment of their patient's dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied). | Week 4 |
| Tear Break Up Time (TBUT) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with dry eye
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stuttgart | Baden-Wurttemberg | Germany |
Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice. There was no investigational drug administered in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | OPTIVE PLUS® | Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | OPTIVE PLUS® | Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS® | Patients rated their satisfaction with OPTIVE PLUS® as treatment for dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied). | All participants with data available for this outcome measure. | Posted | Number | Participants | Week 4 |
|
|
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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 | OPTIVE PLUS® | Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract operation | Eye disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | 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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TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The longer it takes, the more stable the tear film. |
| Baseline, Week 4 |
| Schirmer Score | The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. | Baseline, Week 4 |
| Participants |
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| Sex/Gender, Customized | Number | Participants |
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| Secondary | Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS® | The physician rated their satisfaction with OPTIVE PLUS® for the treatment of their patient's dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied). | All participants with data available for this outcome measure. | Posted | Number | Participants | Week 4 |
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|
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| Secondary | Tear Break Up Time (TBUT) | TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The longer it takes, the more stable the tear film. | All participants with complete data available for this outcome measure at Baseline and Week 4. | Posted | Median | Full Range | Seconds | Baseline, Week 4 |
|
|
|
| Secondary | Schirmer Score | The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. | All participants with complete data available for this outcome measure at Baseline and Week 4. | Posted | Median | Full Range | mm/5 min | Baseline, Week 4 |
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| 2 |
| 1,209 |
| 0 |
| 1,209 |
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 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.