The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Secondary ID [1] 283204 0
Nil known
Universal Trial Number (UTN)
U1111-1147-9002
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry eye disease 290064 0
Condition category
Condition code
Eye 290444 290444 0 0
Diseases / disorders of the eye
Eye 290445 290445 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 287928 0
Treatment: Devices
Comparator / control treatment
Sham (non-functional) device
Control group
Placebo

Outcomes
Primary outcome [1] 290468 0
Mean Schirmer test score compared to baseline
Timepoint [1] 290468 0
At 3 months after start of study treatment
Primary outcome [2] 290469 0
Adverse events - Potential adverse events can include headache, pain/discomfort, and nosebleed, all assessed through case history.
Timepoint [2] 290469 0
At 3 months after start of study treatment
Secondary outcome [1] 304565 0
Mean Ocular Surface Disease Index score compared to baseline
Timepoint [1] 304565 0
At 3 months after start of study treatment
Secondary outcome [2] 304566 0
Mean dry eye symptoms as assessed by a Visual Analogue Scale compared to baseline
Timepoint [2] 304566 0
At 3 months after start of study treatment

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by telephone/fax/computer
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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Prospective
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment outside Australia
Country [1] 5403 0
New Zealand
State/province [1] 5403 0
Auckland; Christchurch; Rotorua

Funding & Sponsors
Funding source category [1] 287947 0
Commercial sector/Industry
Name [1] 287947 0
Oculeve, Inc.
Address [1] 287947 0
395 Oyster Point Blvd, Suite 501
South San Francisco, CA 94080
Country [1] 287947 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Oculeve, Inc.
Address
395 Oyster Point Blvd, Suite 501
South San Francisco, CA 94080
Country
United States of America
Secondary sponsor category [1] 286665 0
Other
Name [1] 286665 0
Five Corners Pty Ltd
Address [1] 286665 0
13/76 Reserve Road
Artarmon NSW 2064
Country [1] 286665 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289874 0
Health & Disability Ethics Committee
Ethics committee address [1] 289874 0
Ministry of Health
No 1 The Terrace
Wellington New Zealand 6011
Ethics committee country [1] 289874 0
New Zealand
Date submitted for ethics approval [1] 289874 0
28/09/2013
Approval date [1] 289874 0
21/11/2013
Ethics approval number [1] 289874 0
Ethics committee name [2] 289977 0
Bellberry HREC
Ethics committee address [2] 289977 0
229 Greenhill Road
Dulwich S.A. 5065
Ethics committee country [2] 289977 0
Australia
Date submitted for ethics approval [2] 289977 0
25/09/2013
Approval date [2] 289977 0
19/11/2013
Ethics approval number [2] 289977 0

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.
Trial website
Trial related presentations / publications
No trial related presentations / publications available.
Public notes

Contacts
Principal investigator
Name 42878 0
Dr Geoff Cohn
Address 42878 0
Eye Associates
Level 4, 187 Macquarie Street
Sydney NSW 2000
Country 42878 0
Australia
Phone 42878 0
+61 2 9247 9972
Fax 42878 0
+61 2 9232 3086
Email 42878 0
trials@eyeassociates.com.au
Contact person for public queries
Name 42879 0
Mr Mark Holdbrook
Address 42879 0
Oculeve, Inc.
395 Oyster Point Blvd, Suite 501
South San Francisco, CA 94080
Country 42879 0
United States of America
Phone 42879 0
+1 415 745 3789
Fax 42879 0
+1 650 7370200
Email 42879 0
mark@oculeve.com
Contact person for scientific queries
Name 42880 0
Dr Geoff Cohn
Address 42880 0
Eye Associates
Level 4, 187 Macquarie Street
Sydney NSW 2000
Country 42880 0
Australia
Phone 42880 0
+61 2 9247 9972
Fax 42880 0
+61 2 9232 3086
Email 42880 0
trials@eyeassociates.com.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary