BriTer Eyez Moisture Vue™ On-Demand Disposable Moisture Chamber
ConditionDry Eye Disease (DED)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester
About this trial
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,
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older
Clinical Diagnosis of mild to moderate dry eye
Individual wears eyeglass spectacles
Disqualifiers
Children under the age of 18 years of age
Women who are currently pregnant or nursing
Adults with decisional impairment
Prisoners
Trial design
Design model
Single group
Treatments tested in this trial
BriTer Eyez Moisture Vue™ On Demand Disposable Moisture Chamber
DeviceA 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.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Moisture Vue™ Device UseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and after 2 hours of device wear.2
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.
Time frame
Baseline and after 2 hours of device wear.3
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.
Time frame
Baseline and after 2 hours of device wear.Secondary outcomes
1
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.
Time frame
Baseline and after 2 hours of device wear.2
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.
Time frame
Baseline and after 2 hours of device wear.3
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.
Time frame
After 2 hours of device wear.4
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.
Time frame
Baseline and after 2 hours of device wear.Sponsors and contacts
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Source ClinicalTrials.gov