Back to resultsA Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome
Primary Purpose
Dry Eye Syndrome, Keratoconjunctivitis Sicca
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oculeve Intranasal
Sham
Oculeve Extranasal
Sponsored by
About this trial
This is an interventional supportive care trial for Dry Eye Syndrome
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
Sites / Locations
- The Eye Care Group
- Virginia Eye Consultants
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Sequence 1-Intranasal: Extranasal: Sham
Sequence 2-Intranasal: Sham: Extranasal
Sequence 3-Extranasal: Intranasal: Sham
Sequence 4-Extranasal: Sham: Intranasal
Sequence 5-Sham: Intranasal: Extranasal
Sequence 6-Sham: Extranasal: Intranasal
Arm Description
Oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device, intranasal (control) application, for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Oculeve device, intranasal (test) application for approximately 3 minutes followed by sham device, intranasal (control) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes, followed by sham device (control), intranasal application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Outcomes
Primary Outcome Measures
Acute Stimulated Tear Production
Stimulated acute tear production in the study eye at Day 0 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 study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected. If there was no difference for either measure, the right eye was used as the study eye.
Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE)
An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in participants, users or other persons it does not necessarily have to have a causal relationship with the investigational medical device. Device-related AEs were presented as ocular and non-ocular.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02680158
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 31, 2016 (Actual)
Primary Completion Date
March 31, 2016 (Actual)
Study Completion Date
March 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oculeve, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome, Keratoconjunctivitis Sicca
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Three way cross-over study with 6 sequences.
Masking
Investigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1-Intranasal: Extranasal: Sham
Arm Type
Experimental
Arm Description
Oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device, intranasal (control) application, for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Arm Title
Sequence 2-Intranasal: Sham: Extranasal
Arm Type
Experimental
Arm Description
Oculeve device, intranasal (test) application for approximately 3 minutes followed by sham device, intranasal (control) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Arm Title
Sequence 3-Extranasal: Intranasal: Sham
Arm Type
Experimental
Arm Description
Oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes, followed by sham device (control), intranasal application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Arm Title
Sequence 4-Extranasal: Sham: Intranasal
Arm Type
Experimental
Arm Description
Oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Arm Title
Sequence 5-Sham: Intranasal: Extranasal
Arm Type
Experimental
Arm Description
Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Arm Title
Sequence 6-Sham: Extranasal: Intranasal
Arm Type
Experimental
Arm Description
Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Intervention Type
Device
Intervention Name(s)
Oculeve Intranasal
Intervention Description
Oculeve device, intranasal (test) application for approximately 3 minutes.
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
Sham device (control), intranasal application for approximately 3 minutes.
Intervention Type
Device
Intervention Name(s)
Oculeve Extranasal
Intervention Description
Oculeve device, extranasal (control) application for approximately 3 minutes.
Primary Outcome Measure Information:
Title
Acute Stimulated Tear Production
Description
Stimulated acute tear production in the study eye at Day 0 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 study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected. If there was no difference for either measure, the right eye was used as the study eye.
Time Frame
Day 0 post-application
Title
Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE)
Description
An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in participants, users or other persons it does not necessarily have to have a causal relationship with the investigational medical device. Device-related AEs were presented as ocular and non-ocular.
Time Frame
Day 0
Other Pre-specified Outcome Measures:
Title
Corrected Distance Visual Acuity
Time Frame
1-Day
Title
Slit Lamp Biomicroscopy
Time Frame
1-Day
Title
Pulse Rate
Time Frame
1-Day
Title
Oxygen Saturation
Time Frame
1-Day
Title
Blood Pressure
Time Frame
1-Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Senchyna
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
The Eye Care Group
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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
Learn more about this trial
A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome
We'll reach out to this number within 24 hrs