Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04837807 |
| Other study ID # |
IRB-30007063 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
August 18, 2021 |
| Est. completion date |
November 19, 2021 |
Study information
| Verified date |
October 2022 |
| Source |
University of Alabama at Birmingham |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
