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Trial registered on ANZCTR
Registration number
ACTRN12613001110774
Ethics application status
Approved
Date submitted
2/10/2013
Date registered
3/10/2013
Date last updated
7/06/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Stimulation Therapy to Produce Tears for the Treatment of Dry Eye
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Scientific title
Neurostimulation to Increase Tear Production Measured Objectively via Schirmer Test in Adult Patients with Moderate to Severe Dry Eye Disease – A Multicenter Study
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Secondary ID [1]
283204
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Nil known
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Universal Trial Number (UTN)
U1111-1147-9002
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dry eye disease
290064
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Condition category
Condition code
Eye
290444
290444
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0
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Diseases / disorders of the eye
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Eye
290445
290445
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0
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Normal eye development and function
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Arm 1: Neurostimulation device (EMS 2000) - Lacrimal gland neurostimulation. The current provided is approximately 1 milliamp with the patient controlling the amplitude with a knob. The recommended duration of treatment is approximately 30 seconds and the recommended treatment frequency is four times per day or as needed. The duration of the intervention period is 3 months.
Adherence to the intervention will be monitored by questioning of participants by study staff with responses recorded on case report forms.
Arm 2: Sham (non-functional) device
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Intervention code [1]
287928
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Treatment: Devices
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Comparator / control treatment
Sham (non-functional) device
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Mean Schirmer test score compared to baseline
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Assessment method [1]
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Timepoint [1]
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At 3 months after start of study treatment
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Primary outcome [2]
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Adverse events - Potential adverse events can include headache, pain/discomfort, and nosebleed, all assessed through case history.
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Assessment method [2]
290469
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Timepoint [2]
290469
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At 3 months after start of study treatment
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Secondary outcome [1]
304565
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Mean Ocular Surface Disease Index score compared to baseline
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Assessment method [1]
304565
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Timepoint [1]
304565
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At 3 months after start of study treatment
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Secondary outcome [2]
304566
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Mean dry eye symptoms as assessed by a Visual Analogue Scale compared to baseline
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Assessment method [2]
304566
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Timepoint [2]
304566
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At 3 months after start of study treatment
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Eligibility
Key inclusion criteria
Willing to sign the informed consent and deemed capable of following the study protocol; Corneal staining of greater than 2 and sum of corneal and interpalpebral conjunctival staining greater than 7 using Oxford criteria; Basal Schirmer tear test of less than or equal to 7 mm/5 minutes and Schirmer test after nasal stimulation with cotton swab at least 7 mm higher than the basal score; Baseline Ocular Surface Disease Index score of at least 30; Normal lid anatomy, blinking function and closure
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Chronic or recurrent epistaxis; Coagulation disorders that may lead to increased bleeding such as haemophilia and thrombocytopenia; Lacrimal gland, nasal or sinus neoplasia or significant trauma and prior lacrimal gland, nasal or sinus surgery leading to denervation of the gland or nasal passages; Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or electronic device; Diagnosed epilepsy; A systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study or with the frequent assessments required by the study; The history or presence of any ocular disorder or condition in either eye that would likely interfere with the interpretation of the study results or patient safety; Known hypersensitivity to any of the procedural agents or materials in the study device that contact the nasal mucosa; Participation in any clinical trial with a new active substance or a new device during the past 3 months; Women who are pregnant, planning a pregnancy or nursing at study entry
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by telephone/fax/computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Parallel
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Other design features
Prospective
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Because this is a Phase 2 clinical study, no formal hypothesis testing will be performed. Baseline and demographic characteristics will be presented. Continuous variables will be summarized by descriptive statistics (sample size; mean; standard deviation; median; minimum and maximum). Discrete variables will be summarized by frequencies and percentages. Adverse events will be summarized by presenting the number and percentage of participants having any adverse event. Any other information collected (such as severity or relationship to study device) will be listed as appropriate. Any statistical tests performed to explore the data will be used only to highlight any interesting comparisons that may warrant further consideration.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
21/10/2013
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Actual
20/12/2013
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Date of last participant enrolment
Anticipated
1/01/2015
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Actual
9/07/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
61
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment outside Australia
Country [1]
5403
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New Zealand
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State/province [1]
5403
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Auckland; Christchurch; Rotorua
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Funding & Sponsors
Funding source category [1]
287947
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Commercial sector/Industry
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Name [1]
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Oculeve, Inc.
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Address [1]
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395 Oyster Point Blvd, Suite 501
South San Francisco, CA 94080
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Country [1]
287947
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Oculeve, Inc.
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Address
395 Oyster Point Blvd, Suite 501
South San Francisco, CA 94080
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Country
United States of America
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Secondary sponsor category [1]
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Other
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Name [1]
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Five Corners Pty Ltd
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Address [1]
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13/76 Reserve Road
Artarmon NSW 2064
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Country [1]
286665
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289874
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Health & Disability Ethics Committee
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Ethics committee address [1]
289874
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Ministry of Health
No 1 The Terrace
Wellington New Zealand 6011
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Ethics committee country [1]
289874
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New Zealand
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Date submitted for ethics approval [1]
289874
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28/09/2013
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Approval date [1]
289874
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21/11/2013
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Ethics approval number [1]
289874
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Ethics committee name [2]
289977
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Bellberry HREC
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Ethics committee address [2]
289977
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229 Greenhill Road
Dulwich S.A. 5065
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Ethics committee country [2]
289977
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Australia
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Date submitted for ethics approval [2]
289977
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25/09/2013
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Approval date [2]
289977
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19/11/2013
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Ethics approval number [2]
289977
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Summary
Brief summary
The purpose of this study is to demonstrate that neurostimulation increases tear production and improves symptoms of dry eye disease over baseline measurements.
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Trial website
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Trial related presentations / publications
No trial related presentations / publications available.
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Public notes
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Contacts
Principal investigator
Name
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Dr Geoff Cohn
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Address
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Eye Associates
Level 4, 187 Macquarie Street
Sydney NSW 2000
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Country
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Australia
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Phone
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+61 2 9247 9972
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Fax
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+61 2 9232 3086
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Email
42878
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[email protected]
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Contact person for public queries
Name
42879
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Mr Mark Holdbrook
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Address
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Oculeve, Inc.
395 Oyster Point Blvd, Suite 501
South San Francisco, CA 94080
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Country
42879
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United States of America
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Phone
42879
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+1 415 745 3789
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Fax
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+1 650 7370200
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Email
42879
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[email protected]
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Contact person for scientific queries
Name
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Dr Geoff Cohn
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Address
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Eye Associates
Level 4, 187 Macquarie Street
Sydney NSW 2000
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Country
42880
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Australia
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Phone
42880
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+61 2 9247 9972
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Fax
42880
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+61 2 9232 3086
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Email
42880
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Randomized, controlled, double-masked, multicenter, pilot study evaluating safety and efficacy of intranasal neurostimulation for dry eye disease.
2019
https://dx.doi.org/10.1167/iovs.18-23984
N.B. These documents automatically identified may not have been verified by the study sponsor.
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