Digital Device Users Who Are Treated With Systane Hydration PF

NCT ID: NCT04837807

Last Updated: 2022-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-18
• Study Completion Date: 2021-11-19

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.

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Systane Hydration PF

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Systane Hydration PF

Intervention Type: DRUG

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

Interventions

Systane Hydration PF

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Andrew Pucker

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

IRB-30007063

Identifier Type: -

Identifier Source: org_study_id