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Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator

Primary Purpose

Dry Eye Syndromes, Keratoconjunctivitis Sicca

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intranasal Lacrimal Neurostimulator (Oculeve)
Sponsored by
Oculeve, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dry Eye Syndromes

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

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 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

Sites / Locations

  • Cornea & Cataract Consultants of Arizona
  • Andover Eye Associates
  • Total Eye Care

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active - Device

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Corrected Distance Visual Acuity
Change from baseline (Day 0) in corrected distance visual acuity at Day 180. Corrected visual acuity was obtained using the subject's own glasses (for subjects that wear glasses) and measured in logMAR (log of the Minimum Angle of Resolution) units using an appropriate eye chart. A logMAR score of 0.0 is equivalent to a visual acuity of 20/20 and larger logMAR values indicate a poorer visual acuity (eg. A value of 0.3 corresponds to a visual acuity of 20/40).
Slit Lamp Biomicroscopy
Number of subjects with clinically significant (CS) findings noted from the slit lamp biomicroscopy examinations. A slit lamp biomicroscopy examination of the eyelids, cornea, conjunctiva, anterior chamber, and lens was performed at each visit for each eye. The results were graded as normal, abnormal not clinically significant (NCS), or abnormal CS. In addition, the cornea was scored specifically for corneal edema using a 4-point scale (0=None, +1=Mild, +2=Moderate and +3=Severe). An increase in corneal edema grade of two or more was considered clinically significant and evaluated as a potential AE by the investigator.

Full Information

First Posted
August 14, 2015
Last Updated
September 27, 2017
Sponsor
Oculeve, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02526290
Brief Title
Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator
Official Title
Single-Arm, Multicenter, Open-Label Study to Evaluate the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Participants With Aqueous Tear Deficient Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 31, 2015 (Actual)
Primary Completion Date
April 30, 2016 (Actual)
Study Completion Date
April 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oculeve, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the Oculeve Intranasal Lacrimal Neurostimulator to stimulate tear production for 180 days. Participants will have a Screening Visit within 60 days prior to the initial device application. Device application will be initiated at Day 0, at which time participants will receive training on the proper use of the device. Participants will receive follow-up visits at Days 7, 30, 90 and 180.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Keratoconjunctivitis Sicca

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active - Device
Arm Type
Experimental
Arm Description
The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration.
Intervention Type
Device
Intervention Name(s)
Intranasal Lacrimal Neurostimulator (Oculeve)
Intervention Description
Neurostimulation device
Primary Outcome Measure Information:
Title
Stimulated Acute Tear Production
Description
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.
Time Frame
The stimulated and prestimulation (basal) measures were both performed at Day 180.
Secondary Outcome Measure Information:
Title
Corrected Distance Visual Acuity
Description
Change from baseline (Day 0) in corrected distance visual acuity at Day 180. Corrected visual acuity was obtained using the subject's own glasses (for subjects that wear glasses) and measured in logMAR (log of the Minimum Angle of Resolution) units using an appropriate eye chart. A logMAR score of 0.0 is equivalent to a visual acuity of 20/20 and larger logMAR values indicate a poorer visual acuity (eg. A value of 0.3 corresponds to a visual acuity of 20/40).
Time Frame
Baseline and 6 months
Title
Slit Lamp Biomicroscopy
Description
Number of subjects with clinically significant (CS) findings noted from the slit lamp biomicroscopy examinations. A slit lamp biomicroscopy examination of the eyelids, cornea, conjunctiva, anterior chamber, and lens was performed at each visit for each eye. The results were graded as normal, abnormal not clinically significant (NCS), or abnormal CS. In addition, the cornea was scored specifically for corneal edema using a 4-point scale (0=None, +1=Mild, +2=Moderate and +3=Severe). An increase in corneal edema grade of two or more was considered clinically significant and evaluated as a potential AE by the investigator.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Device-related Adverse Events
Description
Number of subjects who experienced any device-related adverse events.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Holland, MD
Organizational Affiliation
Cincinnati Eye Institute
Official's Role
Study Director
Facility Information:
Facility Name
Cornea & Cataract Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Total Eye Care
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30472141
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.
Results Reference
derived

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Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator

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