At a glance
ClinicalIndex Comparison RecordN/ACompleted· 21 enrolled
Drug / intervention
Intranasal Tear Neurostimulatordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single Center, Randomized, Controlled, Single-Masked, Cross-Over Clinical Pilot Study to Evaluate the Reduction in the Exacerbation of the Symptoms of Dry Eye Upon Exposure to a Controlled Adverse Environment (CAESM) With Treatment by the Oculeve Nasal Lacrimal TENS Unit
In Brief
A clinical study evaluating Intranasal Tear Neurostimulator for Dry Eye Syndromes. Completed, enrolled 21 participants across 1 site.
Detailed Summary
The purpose of this study was to evaluate the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally compared with the same device applied extranasally (control) in treating the symptoms of dry eye exacerbated by the Controlled Adverse Environment (CAE) Model.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndromes
CountriesUnited States
CollaboratorsORA, Inc.
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartNov 2014
First PostedDec 2014
Primary CompletionApr 2015
TodayJul 2026
First PostedDec 10, 2014
Enrollment StartNov 17, 2014
Primary CompletionApr 8, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.6 years ago
Interventions
Intranasal Tear Neurostimulatordevice
Neurostimulation applied intranasally and extranasally.