Digital Device Users Who Are Treated With Systane Hydration PF

October 6, 2022 updated by: Andrew Pucker, University of Alabama at Birmingham

Understanding Quality of Life in High Digital Device Users Who Are Treated With Systane Hydration PF

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Unit Dose First, Then Multi-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.
This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies.
EXPERIMENTAL: Multi Dose, Then Unit 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.
This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IDEEL (Impact of Dry Eye on Daily Life) Quality of Life - Work Subsection
Time Frame: 2 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (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
Ocular Surface Disease Index (OSDI) Questionnaire
Time Frame: 2 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 18, 2021

Primary Completion (ACTUAL)

November 19, 2021

Study Completion (ACTUAL)

November 19, 2021

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (ACTUAL)

April 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 10, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-30007063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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