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Digital Device Users Who Are Treated With Systane Hydration PF

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Systane Hydration PF
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring Digital Eye Strain, Dry Eye, Artificial Tears, Eye Comfort

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Unit Dose First, Then Multi-Dose

Multi Dose, Then Unit Dose

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).

Full Information

First Posted
April 6, 2021
Last Updated
October 6, 2022
Sponsor
University of Alabama at Birmingham
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT04837807
Brief Title
Digital Device Users Who Are Treated With Systane Hydration PF
Official Title
Understanding Quality of Life in High Digital Device Users Who Are Treated With Systane Hydration PF
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 18, 2021 (Actual)
Primary Completion Date
November 19, 2021 (Actual)
Study Completion Date
November 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Alcon Research

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Digital Eye Strain, Dry Eye, Artificial Tears, Eye Comfort

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
All subjects will be treated with Systane Hydration PF. Half will start with the unit-dose version and half with start with the multi-dose version. Subjects will switch to the other dosing option in the middle of the study.
Masking
Participant
Masking Description
Investigators will be masked to the dosage group. Subjects will not be masked because it is not possible with the dosage interventions.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unit Dose First, Then Multi-Dose
Arm Type
Experimental
Arm Description
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.
Arm Title
Multi Dose, Then Unit Dose
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Systane Hydration PF
Intervention Description
This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies.
Primary Outcome Measure Information:
Title
IDEEL (Impact of Dry Eye on Daily Life) Quality of Life - Work Subsection
Description
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).
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Drop Dispensing Method Preference
Description
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).
Time Frame
Between groups at 2 weeks
Title
Ocular Surface Disease Index (OSDI) Questionnaire
Description
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).
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Digital Device Users Who Are Treated With Systane Hydration PF

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