Dry EyeNCT03332342
Closed Eye Neutrophils in Dry Eye Disease
A study testing Eye wash in people with Dry Eye and Ocular Inflammation, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this prospective study is to evaluate different inflammatory cells that accumulate on the ocular surface, during sleep, and how these cells may contribute to dry eye disease. This study will involve at-home self-collection of tears using an eye wash method with sterile saline solution. 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, Ocular Inflammation
- What is being tested?
- Eye wash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2017to 14 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- able to understand and sign an informed consent and HIPAA privacy document
- greater than 18 years of age at time of informed consent
- able and willing to follow protocol instructions, including performing at-home washes of the ocular surface and subsequent delivery of those samples to campus on a regular basis
- must be willing to have blood drawn
Who cannot join
- contact lens wear within past three months
- current consumption of cigarettes or tobacco, including e-cigarettes
- participation in any investigational drug studies within 30 days of informed consent
- pregnancy, by self-report
- active ocular infection or inflammation
- any refractive surgery within the past year
Show all 9Show fewer
- any present Accutane (Isotretinoin) use
- any medication usage that, in the investigator's opinion, could be expected to interfere with the study, such as current use of topical steroids, Restasis, or Xiidra
- have any uncontrolled systemic disease, that in the investigator's opinion could be expected to interfere with the study, for example, conditions associated with dry eye disease
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: Impact of Closed Eye Neutrophils on Dry Eye Disease Pathogenesis: Investigation on Repeatability and Effectiveness of an Eye Wash at Awakening for Diagnosis and Therapy
The purpose of this prospective study is to evaluate different inflammatory cells that accumulate on the ocular surface, during sleep, and how these cells may contribute to dry eye disease. This study will involve at-home self-collection of tears using an eye wash method with sterile saline solution. While a diagnostic technique, the eye wash may also have a therapeutic benefit in dry eye sufferers, which will be assessed in the second phase of this project.
Read the detailed description
Every night during sleep, there is an influx of white blood cells on to the surface of the eye. These cells likely perform a protective function, but it is also possible that their dysregulation could lead to disease. Using a larger cohort, our investigation hopes to better understand the function of these cells and their potential to be linked to dry eye disease. Further, the way in which these cells are collected, using an at-home self-collection of tears using an eye wash method with sterile saline solution, immediately upon awakening, could potentially provide relief to dry eye sufferers if performed on a daily basis.
- Conditions
- Dry Eye, Ocular Inflammation
- Being tested
- Eye wash
- Keywords
- dry eye disease, tears, inflammation, ocular surface
- Medical subject headings
- Dry Eye Syndromes, Lacerations, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye washOther
Research subjects will perform a wash of their ocular surface with phosphate buffered saline
| Study group | Role | What they receive |
|---|---|---|
| Daily rinse of ocular surface | Experimental | Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed daily. Receives: Other: Eye wash |
| Weekly rinse of ocular surface | Active comparator | Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed weekly. Receives: Other: Eye wash |
| Occasional rinse of ocular surface | Experimental | Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed on two separate occasions Receives: Other: Eye wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort assessment using the dry eye questionnaire
Mean change from baseline in comfort following daily ocular surface washes
Measured: Baseline to 4 weeks
Comfort assessment using the ocular surface disease index
Mean change from baseline in comfort following daily ocular surface washes
Measured: Baseline to 4 weeks
Secondary outcomes (2)
Repeatability of diagnostic in measuring leukocyte count
Repeatability of the eye wash in terms of leukocyte count, as measured by flow cytometry
Measured: Baseline to 4 weeks
Repeatability of diagnostic in measuring leukocyte phenotype
Repeatability of the eye wash in terms of leukocyte phenotype, as measured by flow cytometry
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start8 Nov 2017
- Primary completion12 Dec 2018
- Study completion14 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan Sales, LLC
- Responsible party
- Principal investigator, Kelly Nichols, University of Alabama at Birmingham
- Investigators
- Kelly K Nichols, OD MPH PhD, Principal investigator, UAB School of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332342
- Sponsor's protocol ID
- 000517538
- Status last verified
- May 2019
- First submitted
- 25 Oct 2017
- Last updated
- 17 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Closed Eye Neutrophils on Dry Eye Disease Pathogenesis: Investigation on Repeatability and Effectiveness of an Eye Wash at Awakening for Diagnosis and Therapy
- ClinicalTrials.gov ID
- NCT03332342
- Acronym / sponsor ID
- 000517538
- Conditions
- Dry Eye, Ocular Inflammation
- Keywords
- dry eye disease, tears, inflammation, ocular surface
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Allergan Sales, LLC
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 14 May 2019 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this prospective study is to evaluate different inflammatory cells that accumulate on the ocular surface, during sleep, and how these cells may contribute to dry eye disease. This study will involve at-home self-collection of tears using an eye wash method with sterile saline solution. While a diagnostic technique, the eye wash may also have a therapeutic benefit in dry eye sufferers, which will be assessed in the second phase of this project.
Detailed description
Every night during sleep, there is an influx of white blood cells on to the surface of the eye. These cells likely perform a protective function, but it is also possible that their dysregulation could lead to disease. Using a larger cohort, our investigation hopes to better understand the function of these cells and their potential to be linked to dry eye disease. Further, the way in which these cells are collected, using an at-home self-collection of tears using an eye wash method with sterile saline solution, immediately upon awakening, could potentially provide relief to dry eye sufferers if performed on a daily basis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Daily rinse of ocular surface | Experimental | Other: Eye washEye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed daily. |
| Weekly rinse of ocular surface | Active comparator | Other: Eye washEye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed weekly. |
| Occasional rinse of ocular surface | Experimental | Other: Eye washEye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed on two separate occasions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- able to understand and sign an informed consent and HIPAA privacy document
- greater than 18 years of age at time of informed consent
- able and willing to follow protocol instructions, including performing at-home washes of the ocular surface and subsequent delivery of those samples to campus on a regular basis
- must be willing to have blood drawn
Key exclusion criteria (9 listed)
- contact lens wear within past three months
- current consumption of cigarettes or tobacco, including e-cigarettes
- participation in any investigational drug studies within 30 days of informed consent
- pregnancy, by self-report
- active ocular infection or inflammation
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 |
|---|---|---|
| Eye washResearch subjects will perform a wash of their ocular surface with phosphate buffered saline | Other | Daily rinse of ocular surface, Occasional rinse of ocular surface, Weekly rinse of ocular surface |
Primary outcome
Comfort assessment using the dry eye questionnaire
Time frame: Baseline to 4 weeks
Mean change from baseline in comfort following daily ocular surface washes
Comfort assessment using the ocular surface disease index
Time frame: Baseline to 4 weeks
Mean change from baseline in comfort following daily ocular surface washes
2 secondary outcomes
Repeatability of diagnostic in measuring leukocyte count
Time frame: Baseline to 4 weeks
Repeatability of diagnostic in measuring leukocyte phenotype
Time frame: Baseline to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- 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.
Kelly K Nichols, OD MPH PhD principal investigator
UAB School of Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye wash in people with Dry Eye and Ocular Inflammation, 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 4 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 17 May 2019. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comfort assessment using the dry eye questionnaire (time frame: Baseline to 4 weeks). The study lists 2 primary outcomes in all. 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 17 May 2019.