At a glance
ClinicalIndex Comparison RecordN/ACompleted· 48 enrolled
Drug / intervention
Oculeve Intranasal +2 moredevice
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 Randomized, Controlled, Double-Masked, Multicenter Trial Designed to Evaluate Acute Tear Production With the Oculeve Intranasal Lacrimal Stimulator Compared to Two Control Applications in Patients With Aqueous Deficient Dry Eye
In Brief
A clinical study evaluating Oculeve Intranasal, Sham, and 1 other intervention for Dry Eye Syndrome and Keratoconjunctivitis Sicca. Completed, enrolled 48 participants across 2 sites.
Detailed Summary
The purpose of this study is to compare acute tear production produced by the Oculeve Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous tear deficiency.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndrome, Keratoconjunctivitis Sicca
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJan 2016
First PostedFeb 2016
Primary CompletionMar 2016
TodayJul 2026
First PostedFeb 11, 2016
Enrollment StartJan 31, 2016
Primary CompletionMar 31, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.4 years ago
Interventions
Oculeve Intranasaldevice
Oculeve device, intranasal (test) application for approximately 3 minutes.
Shamdevice
Sham device (control), intranasal application for approximately 3 minutes.
Oculeve Extranasaldevice
Oculeve device, extranasal (control) application for approximately 3 minutes.