Dry Eye Disease (DED)NCT07430735
BriTer Eyez Moisture Vue™ On-Demand Disposable Moisture Chamber
A study testing BriTer Eyez Moisture Vue™ On Demand Disposable Moisture Chamber in people with Dry Eye Disease (DED), run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the short-term effects (impact on tear film and dry eye symptoms) of the BriTer Eyez Moisture Vue™ On-Demand Disposable Moisture Chamber (the device under investigation) in individuals with mild to moderate dry eye disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- BriTer Eyez Moisture Vue™ On Demand Disposable Moisture Chamber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Clinical Diagnosis of mild to moderate dry eye
- Individual wears eyeglass spectacles
Who cannot join
- Children under the age of 18 years of age
- Women who are currently pregnant or nursing
- Adults with decisional impairment
- Prisoners
- Individuals who have a known ocular or medical condition (other than DED) that impacts their ocular surface and could confound the results of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Nichole Ash, 585-602-3054 ext. 23054, nichole_ash@urmc.rochester.edu
Esteban Santiago
About this study
Official title: A Clinical Evaluation of the BriTer Eyez Moisture Vue™ On-Demand Disposable Moisture Chamber in Subjects With Mild to Moderate Dry Eye Disease
The purpose of this study is to evaluate the short-term effects (impact on tear film and dry eye symptoms) of the BriTer Eyez Moisture Vue™ On-Demand Disposable Moisture Chamber (the device under investigation) in individuals with mild to moderate dry eye disease. Specifically, the study aims to determine whether wearing the device for two hours improves tear-film stability, tear volume, and tear osmolarity,
- Conditions
- Dry Eye Disease (DED)
- Being tested
- BriTer Eyez Moisture Vue™ On Demand Disposable Moisture Chamber
- Keywords
- Dry Eye
- 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.
BriTer Eyez Moisture Vue™ On Demand Disposable Moisture ChamberDevice
A disposable silicone moisture chamber device designed to attach to eyeglass spectacles to increase periocular humidity and reduce tear evaporation. Participants will apply the device bilaterally to their spectacles and wear it for two hours under supervised conditions. Ocular surface parameters and dry eye symptoms will be assessed before and after device wear.
| Study group | Role | What they receive |
|---|---|---|
| Moisture Vue™ Device Use | Experimental | Participants with mild to moderate dry eye disease will wear the BriTer Eyez Moisture Vue™ On Demand Disposable Moisture Chamber attached to their eyeglass spectacles for two hours. Objective tear film measurements and symptom surveys will be collected before and after device wear. Receives: Device: BriTer Eyez Moisture Vue™ On Demand Disposable Moisture Chamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Non-Invasive Tear Break Up Time (NITBUT)
The mean change in non-invasive tear break up time will be measured using the Bruder Ocular Surface Analyzer at baseline and after 2 hours of device wear. NITBUT reflects tear film stability and will be reported as the mean difference between post wear and baseline values in seconds.
Measured: Baseline and after 2 hours of device wear.
Mean Change in Tear Meniscus Height
The mean change in tear meniscus height will be measured using the Bruder Ocular Surface Analyzer at baseline and after 2 hours of device wear. Tear meniscus height is an indicator of tear volume and will be reported as the mean difference between post wear and baseline values in millimeters.
Measured: Baseline and after 2 hours of device wear.
Mean Change in Tear Osmolarity
The mean change in tear osmolarity will be measured using the TearLab Osmolarity System at baseline and after 2 hours of device wear. Tear osmolarity reflects tear film homeostasis and will be reported as the mean difference between post wear and baseline values in milliosmoles per liter.
Measured: Baseline and after 2 hours of device wear.
Secondary outcomes (5)
Mean Change in SPEED Total Score
The mean change in the Standardized Patient Evaluation of Eye Dryness total score will be assessed using the SPEED questionnaire administered at baseline and after 2 hours of device wear. Results will be reported as the mean difference between post wear and baseline total scores.
Measured: Baseline and after 2 hours of device wear.
Mean Change in SANDE Composite Score
The mean change in dry eye symptom severity will be assessed using the Symptom Assessment in Dry Eye questionnaire administered at baseline and after 2 hours of device wear. Results will be reported as the mean difference between post wear and baseline composite scores.
Measured: Baseline and after 2 hours of device wear.
Mean System Usability Scale Total Score
Usability of the moisture chamber device will be assessed using the System Usability Scale administered after device wear. The total usability score will be reported as the mean System Usability Scale score across participants.
Measured: After 2 hours of device wear.
Mean Change in Lipid Layer Thickness Category
The mean change in lipid layer thickness category will be assessed using automated interferometry on the Bruder Ocular Surface Analyzer at baseline and after 2 hours of device wear. Results will be reported as the mean difference in lipid layer category scores.
Measured: Baseline and after 2 hours of device wear.
Mean Change in Blink Rate
The mean change in blink rate will be assessed using automated blink analysis on the Bruder Ocular Surface Analyzer at baseline and after 2 hours of device wear. Results will be reported as the mean difference in blink rate per minute.
Measured: Baseline and after 2 hours of device wear.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Sep 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esteban Santiago, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430735
- Sponsor's protocol ID
- STUDY00011134
- Status last verified
- Sep 2026
- First submitted
- 17 Feb 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the BriTer Eyez Moisture Vue™ On-Demand Disposable Moisture Chamber in Subjects With Mild to Moderate Dry Eye Disease
- ClinicalTrials.gov ID
- NCT07430735
- Acronym / sponsor ID
- STUDY00011134
- Conditions
- Dry Eye Disease (DED)
- Keywords
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 24 Feb 2026 (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 study is to evaluate the short-term effects (impact on tear film and dry eye symptoms) of the BriTer Eyez Moisture Vue™ On-Demand Disposable Moisture Chamber (the device under investigation) in individuals with mild to moderate dry eye disease. Specifically, the study aims to determine whether wearing the device for two hours improves tear-film stability, tear volume, and tear osmolarity,
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moisture Vue™ Device Use | Experimental | Device: BriTer Eyez Moisture Vue™ On Demand Disposable Moisture ChamberParticipants with mild to moderate dry eye disease will wear the BriTer Eyez Moisture Vue™ On Demand Disposable Moisture Chamber attached to their eyeglass spectacles for two hours. Objective tear film measurements and symptom surveys will be collected before and after device wear. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Clinical Diagnosis of mild to moderate dry eye
- Individual wears eyeglass spectacles
Key exclusion criteria (5 listed)
- Children under the age of 18 years of age
- Women who are currently pregnant or nursing
- Adults with decisional impairment
- Prisoners
- Individuals who have a known ocular or medical condition (other than DED) that impacts their ocular surface and could confound the results of the study.
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 |
|---|---|---|
| BriTer Eyez Moisture Vue™ On Demand Disposable Moisture ChamberA disposable silicone moisture chamber device designed to attach to eyeglass spectacles to increase periocular humidity and reduce tear evaporation. Participants will apply the device bilaterally to their spectacles and wear it for two hours under supervised conditions. Ocular surface parameters and dry eye symptoms will be assessed before and after device wear. | Device | Moisture Vue™ Device Use |
Primary outcome
Mean Change in Non-Invasive Tear Break Up Time (NITBUT)
Time frame: Baseline and after 2 hours of device wear.
The mean change in non-invasive tear break up time will be measured using the Bruder Ocular Surface Analyzer at baseline and after 2 hours of device wear. NITBUT reflects tear film stability and will be reported as the mean difference between post wear and baseline values in seconds.
Mean Change in Tear Meniscus Height
Time frame: Baseline and after 2 hours of device wear.
The mean change in tear meniscus height will be measured using the Bruder Ocular Surface Analyzer at baseline and after 2 hours of device wear. Tear meniscus height is an indicator of tear volume and will be reported as the mean difference between post wear and baseline values in millimeters.
Mean Change in Tear Osmolarity
Time frame: Baseline and after 2 hours of device wear.
The mean change in tear osmolarity will be measured using the TearLab Osmolarity System at baseline and after 2 hours of device wear. Tear osmolarity reflects tear film homeostasis and will be reported as the mean difference between post wear and baseline values in milliosmoles per liter.
5 secondary outcomes
Mean Change in SPEED Total Score
Time frame: Baseline and after 2 hours of device wear.
Mean Change in SANDE Composite Score
Time frame: Baseline and after 2 hours of device wear.
Mean System Usability Scale Total Score
Time frame: After 2 hours of device wear.
Mean Change in Lipid Layer Thickness Category
Time frame: Baseline and after 2 hours of device wear.
Mean Change in Blink Rate
Time frame: Baseline and after 2 hours of device wear.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- 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.
University of Rochester Medical Center
Rochester, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BriTer Eyez Moisture Vue™ On Demand Disposable Moisture Chamber in people with Dry Eye Disease (DED), run by University of Rochester 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Non-Invasive Tear Break Up Time (NITBUT) (time frame: Baseline and after 2 hours of device wear.). The study lists 3 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 11 Sep 2026.