BriTer Eyez Moisture Vue™ On-Demand Disposable Moisture Chamber

May 12, 2026 updated by: Esteban Santiago, University of Rochester

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,

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center
        • Contact:
        • Principal Investigator:
          • Esteban Santiago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moisture Vue™ Device Use
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.
Device: BriTer Eyez Moisture Vue™ On Demand Disposable Moisture Chamber
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after 2 hours of device wear.
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.
Baseline and after 2 hours of device wear.
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.
Baseline and after 2 hours of device wear.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in SPEED Total Score
Time Frame: Baseline and after 2 hours of device wear.
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.
Baseline and after 2 hours of device wear.
Mean Change in SANDE Composite Score
Time Frame: Baseline and after 2 hours of device wear.
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.
Baseline and after 2 hours of device wear.
Mean System Usability Scale Total Score
Time Frame: After 2 hours of device wear.
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.
After 2 hours of device wear.
Mean Change in Lipid Layer Thickness Category
Time Frame: Baseline and after 2 hours of device wear.
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.
Baseline and after 2 hours of device wear.
Mean Change in Blink Rate
Time Frame: Baseline and after 2 hours of device wear.
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.
Baseline and after 2 hours of device wear.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00011134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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