Digital Device Users Who Are Treated With Systane Hydration PF

Overview

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.

Full Title of Study: “Understanding Quality of Life in High Digital Device Users Who Are Treated With Systane Hydration PF”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 31, 2021

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

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

Arms, Groups and Cohorts

  • Experimental: Unit Dose
    • Subjects randomized to this group will apply the unit-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain.
  • Experimental: Multi Dose
    • Subjects randomized to this group will apply multi-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain.

Clinical Trial Outcome Measures

Primary Measures

  • IDEEL (Impact of Dry Eye on Daily Life) Quality of Life – Work Subsection
    • Time Frame: Baseline to 2 weeks
    • 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).

Secondary Measures

  • Drop Dispensing Method Preference
    • Time Frame: 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.
  • Ocular Surface Disease Index (OSDI) Questionnaire
    • Time Frame: Baseline to 2 weeks
    • The OSDI will be self-administered electronically to understand how treatment with Systane Hydration PF helps a patient’s ability to work (0-100 scale).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Alabama at Birmingham
  • Collaborator
    • Alcon Research
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andrew Pucker, Assistant Professor – University of Alabama at Birmingham
  • Overall Contact(s)
    • Andrew D Pucker, OD, MS, PhD, 920-579-2900, apucker@uab.edu

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