NCT07430735

Brief Summary

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,

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

May 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

February 17, 2026

Last Update Submit

May 12, 2026

Conditions

Dry Eye Disease (DED)

Keywords

Dry Eye

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline and after 2 hours of device wear.

Secondary Outcomes (5)

  • Mean Change in SPEED Total Score

    Baseline and after 2 hours of device wear.

  • Mean Change in SANDE Composite Score

    Baseline and after 2 hours of device wear.

  • Mean System Usability Scale Total Score

    After 2 hours of device wear.

  • Mean Change in Lipid Layer Thickness Category

    Baseline and after 2 hours of device wear.

  • Mean Change in Blink Rate

    Baseline and after 2 hours of device wear.

Study Arms (1)

Moisture Vue™ Device Use

EXPERIMENTAL

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

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.

Moisture Vue™ Device Use

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Clinical Diagnosis of mild to moderate dry eye
  • Individual wears eyeglass spectacles

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Department of Ophthalmology

Study Record Dates

First Submitted

February 17, 2026

First Posted

February 24, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

May 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)