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Recruiting NCT07430735

BriTer Eyez Moisture Vue™ On-Demand Disposable Moisture Chamber

No phase Interventional Dry Eye Disease (DED)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BriTer Eyez Moisture Vue™ On Demand Disposable Moisture Chamber.
Who it may be relevant to
Registry conditions: Dry Eye Disease (DED). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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,

Interventions

  • 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.

Primary outcome measures

  • Mean Change in Non-Invasive Tear Break Up Time (NITBUT) [Time frame: Baseline and after 2 hours of device wear.]
  • Mean Change in Tear Meniscus Height [Time frame: Baseline and after 2 hours of device wear.]
  • Mean Change in Tear Osmolarity [Time frame: Baseline and after 2 hours of device wear.]
Secondary outcome measures (5)
  • Mean Change in SPEED Total Score [Time frame: Baseline and after 2 hours of device wear.]
  • Mean Change in SANDE Composite Score [Time frame: Baseline and after 2 hours of device wear.]
  • Mean System Usability Scale Total Score [Time frame: After 2 hours of device wear.]
  • Mean Change in Lipid Layer Thickness Category [Time frame: Baseline and after 2 hours of device wear.]
  • Mean Change in Blink Rate [Time frame: Baseline and after 2 hours of device wear.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Rochester Medical Center — Rochester

Identifiers

NCT: NCT07430735 · STUDY00011134

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗