Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2025-12-17 @ 2:18 AM
Study NCT ID:
NCT04837807
Status:
None
Last Update Posted:
2022-10-10 00:00:00
First Post:
2021-04-06 00:00:00
Brief Title:
Digital Device Users Who Are Treated With Systane Hydration PF
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Understanding Quality of Life in High Digital Device Users Who Are Treated With Systane Hydration PF
Status:
None
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 eg 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 surfaces moisture while simultaneously soothing the eye Systane Hydration PF has HydroBoost technology which is thought to enhance the drops 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 patients 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
Systane Hydration PF is a recently released preservative-free artificial tear that is able to supplement the ocular surfaces moisture while simultaneously soothing the eye Systane Hydration PF has HydroBoost technology which is thought to enhance the drops 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None