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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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 19, 2021
Est. primary completion date November 19, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Systane Hydration PF
This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies.

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (2)

Lead Sponsor Collaborator
University of Alabama at Birmingham Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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). 2 weeks
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). Between groups at 2 weeks
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). 2 weeks
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