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The goal of this research is to evaluate and compare the effectiveness of Systane® versus Optive™ on aqueous tear film stability in patients with a diagnosis of Dry Eye Syndrome and to determine the possible application for this product in the future. Systane® is marketed as over-the-counter tear lubricating therapy in the United States under the FDA monograph.
Twenty (20) patients will be enrolled in this two-period crossover, randomized study design. During the course of the study, each patient will be treated with each test article in the clinic at separate visits. Following the informed consent procedure, a general ocular evaluation, including corneal and conjunctival staining and Schirmer testing, will be done and evaporometry assessments will be completed to determine baseline tear evaporation rate. This will occur before any test article is administered to the patient.
Qualified patients will be randomized into two treatment groups. After 1 hour, in order to eliminate any residual sodium fluorescein, patients will be administered one drop of Systane® (40 µl) or Optive™ (40 µl) in each eye per randomization assignment. At 30 minutes following instillation of the drop, the evaporometry measurement will be repeated. These evaporometry tests (pre and post instillation of drops) will be performed in order to establish a comparison for later analysis. The estimated time in completing each study visit will be 180 minutes per visit. Patients will be asked to return to the clinic after 2 - 14 days for evaluation of the 2nd assigned crossover treatment (i.e. patients who initially received Optive will receive Systane and patients who initially received Systane will receive Optane).
During the interim study periods, patients will be asked to continue their pre-study routine; using their pre-study ocular lubricant or other tear products at the same frequency. Any changes in the frequency of product use during the interim period or any changes in other concomitant medications will be carefully recorded. This is especially important since many prescription products (e.g., Claritan) have significant effects on lacrimal gland physiology.
An effort will be made to schedule all study visits at approximately the same time of day in order to reduce diurnal variability. For the similar reasons, all patients will be asked not to use any lubricants or ocular medications for at least one hour prior to their office visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optive, then Systane Artificial Tears | Active Comparator | Artificial Tears (Optive, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, artificial tears (Systane, 40 microliters) will be administered using the same procedure protocol. |
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| Systane, then Optive Artificial Tears | Active Comparator | Artificial Tears (Systane, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, artificial tears (Optive, 40 microliters) will be administered using the same procedure protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1st visit Optive, then 2nd visit Systane | Drug | First visit: Instillation of Optive followed by evaporometry assessment after 30 minutes. Second visit: Instillation of Systane followed by evaporometry assessment after 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Aqueous Tear Evaporation Rate Before and After Use of OTC Artificial Tears | To evaluate the effect of OTC artificial tears on tear film stability, the evaporation rate (µl/cm2/min) will be determined with an Evaporometer for the left eye only of each patient. For each arm, the evaporation rates will be determined at baseline and at 30 minutes after installation of artificial tears. Evaporation rates in all cases will be determined under two different relative humidity (RH) conditions, RH from 25-35% and RH from 35-45%. | Baseline and 30 minutes after artificial tear instillation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vinod Mootha, MD | UTSW Medical Center at Dallas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTSW Medical Center at Dallas - Aston Ambulatory Care Center | Dallas | Texas | 75390-9057 | United States |
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Subjects with dry eye disease will be recruited from Ophthalmology clinic patients and otherwise healthy volunteers who are students or employees of the University of Texas Southwestern Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Optive, Then Systane Artificial Tears | Artificial Tears (Optive, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, a baseline evaporation rate will be measured, artificial tears (Systane, 40 microliters) will be administered, and evaporation rate measurements will be repeated 30 minutes later. |
| FG001 | Systane, Then Optane Artificial Tears | Artificial Tears (Systane, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, a baseline evaporation rate will be measured, artificial tears (Optane, 40 microliters) will be administered, and evaporation rate measurements will be repeated 30 minutes later. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Optive, Then Systane | Artificial Tears (Optive, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, a baseline evaporation rate will be measured, artificial tears (Systane, 40 microliters) will be administered, and evaporation rate measurements will be repeated 30 minutes later. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Aqueous Tear Evaporation Rate Before and After Use of OTC Artificial Tears | To evaluate the effect of OTC artificial tears on tear film stability, the evaporation rate (µl/cm2/min) will be determined with an Evaporometer for the left eye only of each patient. For each arm, the evaporation rates will be determined at baseline and at 30 minutes after installation of artificial tears. Evaporation rates in all cases will be determined under two different relative humidity (RH) conditions, RH from 25-35% and RH from 35-45%. | Total participant enrollment is 20 (3 men and 17 women). Ten participants were assigned to each sequence, so a total of 20 participants experienced each intervention. | Posted | Mean | Standard Deviation | (µl/cm2/min) | Baseline and 30 minutes after artificial tear instillation |
|
Adverse events were collected for each participant for up to 2 weeks, from time of enrollment to completion of study visits,
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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 Artificial Tears | Artificial Tears (Optive, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Chen | UT Southwestern Medical Center | 214-648-3837 | peter.chen@utsouthwestern.edu |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| 1st visit Systane, then 2nd visit Optive | Drug | First visit: Instillation of Systane followed by evaporometry assessment after 30 minutes. Second visit: Instillation of Optive followed by evaporometry assessment after 30 minutes. |
|
| BG001 | Systane, Then Optive | Artificial Tears (Systane, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, a baseline evaporation rate will be measured, artificial tears (Optane, 40 microliters) will be administered, and evaporation rate measurements will be repeated 30 minutes later. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Systane Artificial Tears | Artificial Tear Artificial Tears (Systane, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, a baseline evaporation rate will be measured, artificial tears (Optane, 40 microliters) will be administered, and evaporation rate measurements will be repeated 30 minutes later. |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Systane Artificial Tears | Artificial Tears (Systane, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. | 0 | 20 | 0 | 20 | 0 | 20 |
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