Dry Eye
Conditions
Keywords
Digital Eye Strain, Dry Eye, Artificial Tears, Eye Comfort
Brief summary
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.
Detailed description
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.
Interventions
DRUGSystane Hydration PF
This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies.
Sponsors
Alcon Research
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Investigators will be masked to the dosage group. Subjects will not be masked because it is not possible with the dosage interventions.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years or older * Using digital devices 8 or more hours per day * Eyes that are dry, irritated, itchy or burn while using a digital screen, like a computer or smartphone * Eye fatigue from digital screen use * Impact of Dry Eye on Daily Life (IDEEL) Work score ≤80 * Ocular Surface Disease Index (OSDI) score between 13 and 32 (inclusive) * Willing to discontinue current artificial tears for at least 24 hours before enrollment
Exclusion criteria
* Pregnant or breastfeeding * Are currently using isotretinoin-derivatives or other ocular medications * Having any active ocular infection or inflammation * History of severe ocular trauma * Ocular surgery within the past 12 months * Having any known systemic health conditions that are thought to alter tear film physiology (e.g., Sjögren's syndrome * Using a dry eye treatment other than artificial tears * Currently using artificial tears more than 4 times per day * Contact lens wear within the past week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IDEEL (Impact of Dry Eye on Daily Life) Quality of Life - Work Subsection | 2 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drop Dispensing Method Preference | Between groups at 2 weeks | 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). |
| Ocular Surface Disease Index (OSDI) Questionnaire | 2 weeks | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Sequence (Week 1) | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 30 Participants | — |
| Age, Continuous | 28.6 Years STANDARD_DEVIATION 12 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 30 participants | — |
| Sex: Female, Male Female | 21 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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).
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Unit Dose | IDEEL (Impact of Dry Eye on Daily Life) Quality of Life - Work Subsection | 81.4 score on a scale | Standard Deviation 12.7 |
| Multi Dose | IDEEL (Impact of Dry Eye on Daily Life) Quality of Life - Work Subsection | 81.4 score on a scale | Standard Deviation 12.7 |
Comparison: Each participant in the study was asked to complete the IDEEL work at their baseline, week 1 and week 2 visits. The IDEEL work is graded on a scale to 100 with higher numbers being deemed as better scores thus representing more comfort than previous weeks.p-value: <0.05ANOVA
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).
Time frame: Between groups at 2 weeks
Population: One person discontinued after the baseline visit and thus did not crossover between groups.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unit Dose | Drop Dispensing Method Preference | 16 Participants |
| Multi Dose | Drop Dispensing Method Preference | 13 Participants |
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).
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unit Dose | Ocular Surface Disease Index (OSDI) Questionnaire | 14.3 score on a scale | Standard Deviation 8.6 |
| Multi Dose | Ocular Surface Disease Index (OSDI) Questionnaire | 14.3 score on a scale | Standard Deviation 8.6 |
p-value: <0.05ANOVA