Digital Device Users Who Are Treated With Systane Hydration PF

NCT04837807 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB-30007063
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Keywords

Digital Eye Strain; Dry Eye; Artificial Tears; Eye Comfort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Drop Dispensing Method Preference

  Between groups at 2 weeks

• Ocular Surface Disease Index (OSDI) Questionnaire

  2 weeks

Study Arms (2)

Unit Dose First, Then Multi-Dose

EXPERIMENTAL

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.

Drug: Systane Hydration PF

Multi Dose, Then Unit Dose

EXPERIMENTAL

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.

Drug: Systane Hydration PF

Interventions

Systane Hydration PF 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; Unit Dose First, Then Multi-Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Alcon Research: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Dr. Andrew Pucker
• Organization: The University of Alabama at Birmingham

apucker@uab.edu

920-579-2900

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Investigators will be masked to the dosage group. Subjects will not be masked because it is not possible with the dosage interventions.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: August 18, 2021
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: October 10, 2022
• Results First Posted: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)