Dry EyePhase 4NCT04837807
Digital Device Users Who Are Treated With Systane Hydration PF
A Phase 4 study testing Systane Hydration PF in people with Dry Eye, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Systane Hydration PF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2021to 19 Nov 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: 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.
Read the 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
- Being tested
- Systane Hydration PF
- Keywords
- Digital Eye Strain, Dry Eye, Artificial Tears, Eye Comfort
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systane Hydration PFDrug
This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Systane Hydration PF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 weeks
Secondary outcomes (2)
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).
Measured: Between groups at 2 weeks
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).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start18 Aug 2021
- Primary completion19 Nov 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Andrew Pucker, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837807
- Sponsor's protocol ID
- IRB-30007063
- Status last verified
- Oct 2022
- First submitted
- 6 Apr 2021
- Last updated
- 10 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Quality of Life in High Digital Device Users Who Are Treated With Systane Hydration PF
- ClinicalTrials.gov ID
- NCT04837807
- Acronym / sponsor ID
- IRB-30007063
- Conditions
- Dry Eye
- Keywords
- Digital Eye Strain, Dry Eye, Artificial Tears, Eye Comfort
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Posted 10 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Unit Dose First, Then Multi-Dose | Experimental | Drug: Systane Hydration PFSubjects 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. |
| Multi Dose, Then Unit Dose | Experimental | Drug: Systane Hydration PFSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systane Hydration PFThis is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies. | Drug | Multi Dose, Then Unit Dose, Unit Dose First, Then Multi-Dose |
Primary outcome
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 secondary outcomes
Drop Dispensing Method Preference
Time frame: Between groups at 2 weeks
Ocular Surface Disease Index (OSDI) Questionnaire
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Systane Hydration PF in people with Dry Eye, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IDEEL (Impact of Dry Eye on Daily Life) Quality of Life - Work Subsection (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.