CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 55 enrolled
Drug / intervention
Oculeve Intranasal Neurostimulatordevice
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Diagnosis of dry eye disease
  • ✓Able to read, speak, and understand English or Spanish
  • ✓Capable of providing informed consent and complying with study protocol
Key exclusion· 6
  • ✕History of chronic or recurrent nosebleeds, coagulation disorders, or conditions that may cause clinically significant increased bleeding
  • ✕Prior nasal or sinus surgery, nasal cautery, or significant nasal trauma
  • ✕Implanted cardiac pacemaker, defibrillator, or other electronic device
  • ✕Corneal transplant in either or both eyes

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02798289
NCT02798289N/ACompleted
CompareCT.gov

A Single Arm, Multicenter, Open-Label Study Designed to Evaluate Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

Oculeve, Inc.·interventional·Posted Jun 14, 2016·Updated Oct 25, 2017

In Brief

A clinical study evaluating Oculeve Intranasal Neurostimulator for Dry Eye Syndrome and Keratoconjunctivitis Sicca. Completed, enrolled 55 participants across 2 sites.

Detailed Summary

The primary objective of this study is to evaluate acute tear production as measured by tear meniscus height (TMH) captured by optical coherence tomography (OCT) after single use of the Oculeve Intranasal Neurostimulator (OIN) in participants with dry eye.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndrome, Keratoconjunctivitis Sicca
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 14, 2016
Enrollment StartJun 1, 2016
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.0 years ago

Interventions

Oculeve Intranasal Neurostimulatordevice

Neurostimulation device