NCT02526290

Brief Summary

In this study, the safety and effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator after 180 days of use in participants with aqueous tear deficiency will be evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

August 31, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

October 31, 2017

Completed
Last Updated

October 31, 2017

Status Verified

September 1, 2017

Enrollment Period

8 months

First QC Date

August 14, 2015

Results QC Date

July 13, 2017

Last Update Submit

September 27, 2017

Conditions

Dry Eye SyndromesKeratoconjunctivitis Sicca

Outcome Measures

Primary Outcomes (1)

  • Stimulated Acute Tear Production

    Stimulated acute tear production in the study eye at Day 180 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm.

    The stimulated and prestimulation (basal) measures were both performed at Day 180.

Secondary Outcomes (2)

  • Corrected Distance Visual Acuity

    Baseline and 6 months

  • Slit Lamp Biomicroscopy

    6 months

Other Outcomes (1)

  • Device-related Adverse Events

    6 months

Study Arms (1)

Active - Device

EXPERIMENTAL

The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration.

Device: Intranasal Lacrimal Neurostimulator (Oculeve)

Interventions

Intranasal Lacrimal Neurostimulator (Oculeve)DEVICE

Neurostimulation device

Active - Device

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with moderate to severe dry eye disease
  • 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

You may not qualify if:

  • 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 history of application of 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
  • Women who are pregnant, planning a pregnancy, or nursing at the Screening Visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cornea & Cataract Consultants of Arizona

Phoenix, Arizona, 85032, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

Related Publications (1)

  • 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.

    PMID: 30472141DERIVED

MeSH Terms

Conditions

Dry Eye SyndromesKeratoconjunctivitis Sicca

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesKeratoconjunctivitisConjunctivitisConjunctival DiseasesKeratitisCorneal Diseases

Results Point of Contact

Title
Therapeutic Area Head
Organization
Allergan, Inc.
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Edward Holland, MD

    Cincinnati Eye Institute

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2015

First Posted

August 18, 2015

Study Start

August 31, 2015

Primary Completion

April 30, 2016

Study Completion

April 30, 2016

Last Updated

October 31, 2017

Results First Posted

October 31, 2017

Record last verified: 2017-09

Locations

US(3)