Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sengi | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Single site, prospective, double-masked, randomized-controlled, two-arm study of the dry eye symptoms as well as corneal and conjunctival staining in subjects using 2 different eyedrops. Subjects will be assessed at a screening visit, and 2 follow-up visits. Clinical evaluations will include patient questionnaire, tear-breakup time, and slit lamp exam.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systane Complete Multi-Dose PF | Other |
| |
| Walgreen's Lubricant Balance | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systane Complete Multi-Dose PF | Drug | Eyedrop |
| |
| Measure | Description | Time Frame |
|---|---|---|
| SANDE Questionnaire | The Symptom Assessment iN Dry Eye (SANDE) questionnaire. Subjects are asked to place an 'X' on the line to indicate both the frequency and severity of their dry eye symptoms. Each question is scored from 0 to 100. The scores for frequency and severity are used to calculate a total score, where Total Score = square.root[Q1 * Q2]. Higher total score on the questionnaire indicates more frequent or severe dry eye symptoms. | Change from baseline to 2 weeks |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Corneal and Conjunctival Staining | Baseline corneal and conjunctival staining with sodium fluorescein and Wratten filter assessed OU using the Academy of Ophthalmology 5 quadrant scheme. Each quadrant will be graded (0-3) giving a total score (by summation) of 0-15 per eye. A higher score is a worse outcome. | Change from baseline to 2 weeks |
Inclusion Criteria:
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
Exclusion Criteria:
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jay Mashouf, OD | Scripps Poway Eyecare & Optometry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Poway Eyecare & Optometry | San Diego | California | 92131 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Systane Complete Multi-Dose PF | Systane Complete Multi-Dose PF: Eyedrop |
| FG001 | Walgreen's Lubricant Balance | Walgreen's Lubricant Balance: Eyedrop |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Systane Complete Multi-Dose PF | Systane Complete Multi-Dose PF: Eyedrop |
| BG001 | Walgreen's Lubricant Balance | Walgreen's Lubricant Balance: Eyedrop |
| 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 | SANDE Questionnaire | The Symptom Assessment iN Dry Eye (SANDE) questionnaire. Subjects are asked to place an 'X' on the line to indicate both the frequency and severity of their dry eye symptoms. Each question is scored from 0 to 100. The scores for frequency and severity are used to calculate a total score, where Total Score = square.root[Q1 * Q2]. Higher total score on the questionnaire indicates more frequent or severe dry eye symptoms. | Posted | Mean | Standard Deviation | score | Change from baseline to 2 weeks |
|
2 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Systane Complete Multi-Dose PF | Systane Complete Multi-Dose PF: Eyedrop | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jay Mashouf | Scripps Optometric Group | 18585302800 | jaymashouf@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2023 | Mar 4, 2025 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Walgreen's Lubricant Balance |
| Drug |
Eyedrop |
|
| Non-invasive Tear Breakup Time |
| Change from baseline to 2 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Other Pre-specified | Corneal and Conjunctival Staining | Baseline corneal and conjunctival staining with sodium fluorescein and Wratten filter assessed OU using the Academy of Ophthalmology 5 quadrant scheme. Each quadrant will be graded (0-3) giving a total score (by summation) of 0-15 per eye. A higher score is a worse outcome. | Posted | Mean | Standard Deviation | score | Change from baseline to 2 weeks | eyes | eyes |
|
|
|
| Other Pre-specified | Non-invasive Tear Breakup Time | Posted | Mean | Standard Deviation | seconds | Change from baseline to 2 weeks | eyes | eyes |
|
|
|
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Walgreen's Lubricant Balance | Walgreen's Lubricant Balance: Eyedrop | 0 | 35 | 0 | 35 | 0 | 35 |
Not provided
Not provided
Not provided