Clinical trial NCT02680158: A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Keratoconjunctivitis Sicca
Lead sponsor: Oculeve, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-11
Enrollment: 48
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Three way cross-over study with 6 sequences.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: This is a prospective, randomized, controlled, double-masked, multicenter clinical trial in which participants with aqueous tear deficiency will receive three different device applications in a randomized sequence.

Eligibility criteria: Inclusion Criteria:

* Participants with aqueous tear deficiency
* Literate, able to speak English or Spanish, and able to complete questionnaires independently
* Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol

Exclusion Criteria:

* Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding
* Nasal or sinus surgery including nasal cautery or significant trauma
* Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
* Diagnosis of epilepsy
* Corneal transplant in either or both eyes
* Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit
* A woman who is pregnant, planning a pregnancy, or nursing at the Screening Visit

Primary outcomes:
measure: Acute Stimulated Tear Production
timeFrame: Day 0 post-application
measure: Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE)
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
measure: Corrected Distance Visual Acuity
timeFrame: 1-Day
measure: Slit Lamp Biomicroscopy
timeFrame: 1-Day
measure: Pulse Rate
timeFrame: 1-Day
measure: Oxygen Saturation
timeFrame: 1-Day
measure: Blood Pressure
timeFrame: 1-Day
Locations:
city: Waterbury
country: United States
facility: The Eye Care Group
state: Connecticut
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
affiliation: Allergan
name: Michelle Senchyna
role: STUDY_DIRECTOR
References:
citation: Sheppard JD, Torkildsen GL, Geffin JA, Dao J, Evans DG, Ousler GW, Wilson J, Baba SN, Senchyna M, Holland EJ. Characterization of tear production in subjects with dry eye disease during intranasal tear neurostimulation: Results from two pivotal clinical trials. Ocul Surf. 2019 Jan;17(1):142-150. doi: 10.1016/j.jtos.2018.11.009. Epub 2018 Nov 22.