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NCT Number: NCT07430735

BriTer Eyez Moisture Vue™ On-Demand Disposable Moisture Chamber

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,

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Key information

Conditions

Dry Eye Disease (DED) Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location status: Recruiting

Location contact

Esteban Santiago

PRINCIPAL_INVESTIGATOR

Nichole Ash

CONTACT

[email protected]

585-602-3054 ext. 23054

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BriTer Eyez Moisture Vue™ On Demand Disposable Moisture Chamber

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

A Clinical Evaluation of the BriTer Eyez Moisture Vue™ On-Demand Disposable Moisture Chamber in Subjects With Mild to Moderate Dry Eye Disease

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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