Recruiting

BriTer Eyez

Sponsor:

University of Rochester

Code:

NCT07430735

Conditions

Dry Eye Disease (DED)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BriTer Eyez Moisture Vue™ On Demand Disposable Moisture Chamber

Study Details

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,

Conditions

Dry Eye Disease (DED)

Study ID

NCT07430735

Start date

Sep 1, 2026

Status verified date

Sep, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • 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. ]

Central Contacts and Locations

Locations

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Nichole Ash

585-602-3054nichole_ash@urmc.rochester.edu

Principal Investigator:

Esteban Santiago

More Information

Sponsor

University of Rochester

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Keywords

  • Dry Eye

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-09-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.