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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Dry Eye Disease (DED)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings