BriTer Eyez Moisture Vue™ On-Demand Disposable Moisture Chamber

University of Rochester35 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Dry Eye Disease (DED)

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age or older * Clinical Diagnosis of mild to moderate dry eye * Individual wears eyeglass spectacles Exclusion Criteria: * 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.

Locations (1)

University of Rochester Medical Center

Rochester, New York, United States

RECRUITING

Outcomes

Primary Outcomes

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.

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.

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

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.

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.

Data from ClinicalTrials.gov

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