Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:34 AM
Study NCT ID:
NCT07430735
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BriTer Eyez Moisture Vue™ On-Demand Disposable Moisture Chamber
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-02-17', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Non-Invasive Tear Break Up Time (NITBUT)', 'timeFrame': 'Baseline and after 2 hours of device wear.', 'description': '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.'}, {'measure': 'Mean Change in Tear Meniscus Height', 'timeFrame': 'Baseline and after 2 hours of device wear.', 'description': '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.'}, {'measure': 'Mean Change in Tear Osmolarity', 'timeFrame': 'Baseline and after 2 hours of device wear.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Mean Change in SPEED Total Score', 'timeFrame': 'Baseline and after 2 hours of device wear.', 'description': '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.'}, {'measure': 'Mean Change in SANDE Composite Score', 'timeFrame': 'Baseline and after 2 hours of device wear.', 'description': '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.'}, {'measure': 'Mean System Usability Scale Total Score', 'timeFrame': 'After 2 hours of device wear.', 'description': '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.'}, {'measure': 'Mean Change in Lipid Layer Thickness Category', 'timeFrame': 'Baseline and after 2 hours of device wear.', 'description': '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.'}, {'measure': 'Mean Change in Blink Rate', 'timeFrame': 'Baseline and after 2 hours of device wear.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry Eye'], 'conditions': ['Dry Eye Disease (DED)']}, 'descriptionModule': {'briefSummary': '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,'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Clinical Diagnosis of mild to moderate dry eye\n* Individual wears eyeglass spectacles\n\nExclusion Criteria:\n\n* Children under the age of 18 years of age\n* Women who are currently pregnant or nursing\n* Adults with decisional impairment\n* Prisoners\n* 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.'}, 'identificationModule': {'nctId': 'NCT07430735', 'briefTitle': 'BriTer Eyez Moisture Vue™ On-Demand Disposable Moisture Chamber', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'A Clinical Evaluation of the BriTer Eyez Moisture Vue™ On-Demand Disposable Moisture Chamber in Subjects With Mild to Moderate Dry Eye Disease', 'orgStudyIdInfo': {'id': 'STUDY00011134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moisture Vue™ Device Use', 'description': '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.', 'interventionNames': ['Device: BriTer Eyez Moisture Vue™ On Demand Disposable Moisture Chamber']}], 'interventions': [{'name': 'BriTer Eyez Moisture Vue™ On Demand Disposable Moisture Chamber', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Moisture Vue™ Device Use']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Department of Ophthalmology', 'investigatorFullName': 'Esteban Santiago', 'investigatorAffiliation': 'University of Rochester'}}}}