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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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Systane Hydration PF is a recently released preservative-free artificial tear that is able to supplement the ocular surface's moisture while simultaneously soothing the eye. While Systane Hydration PF should in theory improve the symptoms and subsequently the quality of life of patients who have DES, this clinical application has yet to be tested. This drop furthermore is available in both unit-dose and multi-dose options; however, it is unclear if patient perceive a difference between the two dispensing methods. Therefore, the primary purpose of this study is to recruit patients who have DES and to treat them with Systane Hydration PF and determine how regular use of this drop impacts a patient's ocular surface symptoms and overall quality of life. This study will secondarily compare the two dispensing methods to determine if patients prefer one method over the other.
Extensive computer use is no longer an employment-specific challenge. Use of digital devices in work, home, and leisure settings is now the norm, and it is now socially expected. While the introduction of high-powered computers and digital devices have greatly improved many aspects of modern life, the pervasive use of digital devices has caused some patients to develop a condition known as Digital Eye Strain (DES). DES has been reported to be as high as 93% the population depending upon how the condition is defined, and its severity has been found to increase with increased digital device time. DES is a condition where patients experience symptoms such as glare, accommodative dysfunction, defocus, fatigue, discomfort, and dryness from digital device use, and these dry eye symptoms may also result in decreased quality of life. While dryness symptoms in DES are likely multifactorial (e.g., contact lens use, systemic disease status), much of the dryness symptoms in DES are probably due to tear film evaporation secondary to having a reduced number of blinks per minute while using digital devices. Since much of the ocular symptoms associated with DES stem from excessive tear evaporation, artificial tears have become an accepted DES treatment
Systane Hydration PF is a recently released preservative-free artificial tear that is able to supplement the ocular surface's moisture while simultaneously soothing the eye. Systane Hydration PF has HydroBoost technology, which is thought to enhance the drop's effectiveness by incorporating ingredients that increase drop retention. While Systane Hydration PF should in theory improve the symptoms and subsequently the quality of life of patients who have DES, this clinical application has yet to be tested. This drop furthermore is available in both unit-dose and multi-dose options; however, it is unclear if patient perceive a difference between the two dispensing methods. Therefore, the primary purpose of this study is to recruit patients who have DES and to treat them with Systane Hydration PF and determine how regular use of this drop impacts a patient's ocular surface symptoms and overall quality of life. This study will secondarily compare the two dispensing methods to determine if patients prefer one method over the other.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unit Dose First, Then Multi-Dose | Experimental | Subjects randomized to this group will apply the unit-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain. |
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| Multi Dose, Then Unit Dose | Experimental | Subjects randomized to this group will apply multi-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systane Hydration PF | Drug | This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies. |
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| Measure | Description | Time Frame |
|---|---|---|
| IDEEL (Impact of Dry Eye on Daily Life) Quality of Life - Work Subsection | Impact of Dry Eye on Daily Life (IDEEL) Work questions will be self-administered electronically to understand how treatment with Systane Hydration PF helps a patient's ability to work (0-100 scale with 100 being worst and 0 being best). | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Drop Dispensing Method Preference | Subjects will report whether they preferred the unit-dose dispensing method or the multi-dose dispensing method via a forced choice questionnaire (forced choice with patient being required to pick if they like the unit-dose dispensing method or the multi-dose better). | Between groups at 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Unit Dose, Then Multi-dose | The participants first received the unit dose version of Systane Hydrataion PF, there was a one day washout period, and then they received the multi-dose version of Systane Hydration PF. |
| FG001 | Multi Dose, Then Unit Dose | The participants first received the multi-dose version of Systane Hydrataion PF, there was a one day washout period, and then they received the unit-dose version of Systane Hydration PF. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| First Sequence (Week 1) |
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| Washout 1 Day |
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| Second Sequence (Week 2) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Subjects were randomized to either a multi dose group or a unit dose group, each group used either a multi dose or unit does in order to apply Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain. After 1 week subjects were switched from their starting group to the other group to determine which dispensing method was preferred. Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies. |
| Units | Counts |
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| Participants |
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| 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 | IDEEL (Impact of Dry Eye on Daily Life) Quality of Life - Work Subsection | Impact of Dry Eye on Daily Life (IDEEL) Work questions will be self-administered electronically to understand how treatment with Systane Hydration PF helps a patient's ability to work (0-100 scale with 100 being worst and 0 being best). | While we had 30 total subjects enroll we lost one person due to lack of interest in the study. As such she was not switched over to the next group and thus no scores other than baseline were collected. | Posted | Median | Standard Deviation | score on a scale | 2 weeks |
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1 month.
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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 | Unit Dose | Subjects randomized to this group will apply the unit-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain. Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Pucker | The University of Alabama at Birmingham | 920-579-2900 | apucker@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 19, 2021 | Feb 4, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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All subjects will be treated with Systane Hydration PF. Half will start with the unit-dose version and half with start with the multi-dose version. Subjects will switch to the other dosing option in the middle of the study.
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Investigators will be masked to the dosage group. Subjects will not be masked because it is not possible with the dosage interventions.
| Ocular Surface Disease Index (OSDI) Questionnaire |
The Ocular Surface Disease Index (OSDI) will be self-administered electronically to understand how treatment with Systane Hydration PF helps a patient's ability to work (0-100 scale with 100 being worst and 0 being best). |
| 2 weeks |
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| Participants |
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| Age, Continuous | Median | Standard Deviation | Years |
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| Sex: Female, Male | This project featured a total of 30 participants, each participant received both treatments, however one patient was lost to follow up, and thus was not part of the crossover total. | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | The project features only 30 participants, all participants got both treatments however one subject dropped out prior to the crossover and thus was not counted in the crossover total. | Number | participants |
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| OG001 | Multi Dose | Subjects randomized to this group will apply multi-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain. Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies. |
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| Secondary | Drop Dispensing Method Preference | Subjects will report whether they preferred the unit-dose dispensing method or the multi-dose dispensing method via a forced choice questionnaire (forced choice with patient being required to pick if they like the unit-dose dispensing method or the multi-dose better). | One person discontinued after the baseline visit and thus did not crossover between groups. | Posted | Count of Participants | Participants | Between groups at 2 weeks |
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| Secondary | Ocular Surface Disease Index (OSDI) Questionnaire | The Ocular Surface Disease Index (OSDI) will be self-administered electronically to understand how treatment with Systane Hydration PF helps a patient's ability to work (0-100 scale with 100 being worst and 0 being best). | One subject was lost after the baseline visit. Thus OSDI scores for the week 1 and 2 visit could not be calculated for that individual. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
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| 0 |
| 30 |
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| 30 |
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| 30 |
| EG001 | Multi Dose | Subjects randomized to this group will apply multi-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain. Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies. | 0 | 30 | 0 | 30 | 0 | 30 |
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