Phase 4
N=30
Digital Device Users Who Are Treated With Systane Hydration PF
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT04837807 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: IDEEL (Impact of Dry Eye on Daily Life) Quality of Life - Work Subsection — 81.4; 81.4 score on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Systane Hydration PF (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IDEEL (Impact of Dry Eye on Daily Life) Quality of Life - Work Subsection |
81.4; 81.4 | <0.05 sig |
| SECONDARY Drop Dispensing Method Preference |
16; 13 | — |
| SECONDARY Ocular Surface Disease Index (OSDI) Questionnaire |
14.3; 14.3 | <0.05 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT04837807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.