Clinical trial NCT04837807: Digital Device Users Who Are Treated With Systane Hydration PF
Official title: Understanding Quality of Life in High Digital Device Users Who Are Treated With Systane Hydration PF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Keywords: Digital Eye Strain
Dry Eye
Artificial Tears
Eye Comfort
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2021-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: IDEEL (Impact of Dry Eye on Daily Life) Quality of Life - Work Subsection
timeFrame: 2 weeks
Secondary outcomes:
measure: Drop Dispensing Method Preference
timeFrame: Between groups at 2 weeks
measure: Ocular Surface Disease Index (OSDI) Questionnaire
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: