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Trial registered on ANZCTR


Registration number
ACTRN12614000203651
Ethics application status
Not yet submitted
Date submitted
22/02/2014
Date registered
26/02/2014
Date last updated
30/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Stimulation Therapy to Produce Tears for the Treatment of Dry Eye – Part 2
Scientific title
Neurostimulation to Increase Tear Production Measured Objectively via Schirmer Test in Adult Patients with Moderate to Severe Dry Eye Disease – A Multicenter Open-Label Study (Part 2)
Secondary ID [1] 284149 0
Nil
Universal Trial Number (UTN)
U1111-1153-7107
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry eye disease 291233 0
Condition category
Condition code
Eye 291578 291578 0 0
Diseases / disorders of the eye
Eye 291601 291601 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Neurostimulation device (EMS 2000) – Lacrimal gland neurostimulation is administered nasally. 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.
Intervention code [1] 288842 0
Treatment: Devices
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291529 0
Mean Schirmer test score compared to baseline
Timepoint [1] 291529 0
At 3 months after start of study treatment
Primary outcome [2] 291530 0
Adverse events – Possible adverse events can include headache, pain/discomfort, and nosebleed, all assessed through case history
Timepoint [2] 291530 0
At 3 months after start of study treatment
Secondary outcome [1] 306978 0
Mean Ocular Surface Disease Index score compared to baseline
Timepoint [1] 306978 0
At 3 months after start of study treatment
Secondary outcome [2] 306979 0
Mean dry eye symptoms as assessed by a Visual Analogue Scale compared to baseline
Timepoint [2] 306979 0
At 3 months after start of study treatment

Eligibility
Key inclusion criteria
Patients who completed the three month randomized controlled trial, ACTRN12613001110774

Willing to sign the informed consent and deemed capable of following the study protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A change in an ocular or systemic disorder or condition during the previous study judged by the investigator to be incompatible with participation in the study, with patient safety, with the frequent assessments required by the study or confounding to the interpretation of study results

Be currently taking any medication known to cause ocular drying (e.g., cyclosporine, antihistamines, tricyclic antidepressants, anxiolytics, antimuscarinics, beta-blocking agents, diuretics, phenothiazines, steroids, etc.) that has not been used on a stable dosing regimen for 30 days prior to Day 0

Punctal plugs (participants with permanent occlusion of punctal ducts are eligible)

Contact lens use for the duration of the study

Participation in any clinical trial with a new active substance or a new device during the course of the study

Women who are pregnant, planning a pregnancy or nursing at study entry

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Decided to pursue other avenues or research.
Date of first participant enrolment
Anticipated
15/04/2014
Actual
Date of last participant enrolment
Anticipated
1/06/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment postcode(s) [1] 7815 0
2000 - Sydney
Recruitment postcode(s) [2] 7816 0
2032 - Kingsford
Recruitment postcode(s) [3] 7817 0
4122 - Upper Mount Gravatt
Recruitment postcode(s) [4] 7818 0
3006 - Southbank
Recruitment outside Australia
Country [1] 5847 0
New Zealand
State/province [1] 5847 0
Auckland; Christchurch

Funding & Sponsors
Funding source category [1] 288776 0
Commercial sector/Industry
Name [1] 288776 0
Oculeve, Inc.
Country [1] 288776 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Oculeve, Inc.
Address
2 Corporate Dr, Suite 1140
South San Francisco, CA 94080
Country
United States of America
Secondary sponsor category [1] 287474 0
None
Name [1] 287474 0
Address [1] 287474 0
Country [1] 287474 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290619 0
Bellberry HREC
Ethics committee address [1] 290619 0
Ethics committee country [1] 290619 0
Australia
Date submitted for ethics approval [1] 290619 0
26/02/2014
Approval date [1] 290619 0
Ethics approval number [1] 290619 0
EC00444
Ethics committee name [2] 290620 0
Health & Disability Ethics Committee
Ethics committee address [2] 290620 0
Ethics committee country [2] 290620 0
New Zealand
Date submitted for ethics approval [2] 290620 0
03/03/2014
Approval date [2] 290620 0
Ethics approval number [2] 290620 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46466 0
Dr Geoff Cohn, MD
Address 46466 0
Eye Associates
Level 4, 187 Macquarie Street
Sydney NSW 2000
Country 46466 0
Australia
Phone 46466 0
+61 2 9247 9972
Fax 46466 0
+61 2 9232 3086
Email 46466 0
trials@eyeassociates.com.au
Contact person for public queries
Name 46467 0
Daniel Hamilton
Address 46467 0
Oculeve, Inc.
2 Corporate Dr, Suite 1140
South San Francisco, CA 94080
Country 46467 0
United States of America
Phone 46467 0
+1 415 5806236
Fax 46467 0
+1 650 7370331
Email 46467 0
dan@oculeve.com
Contact person for scientific queries
Name 46468 0
Geoff Cohn, MD
Address 46468 0
Eye Associates
Level 4, 187 Macquarie Street
Sydney NSW 2000
Country 46468 0
Australia
Phone 46468 0
+61 2 9247 9972
Fax 46468 0
+61 2 9232 3086
Email 46468 0
trials@eyeassociates.com.au

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
No additional documents have been identified.