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Trial registered on ANZCTR


Registration number
ACTRN12615000745549
Ethics application status
Approved
Date submitted
7/07/2015
Date registered
20/07/2015
Date last updated
3/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring nasal neurostimulation for managing contact lens discomfort
Scientific title
Exploring the potential of nasal neurostimulation to manage contact lens discomfort
Secondary ID [1] 286657 0
CL-001
Universal Trial Number (UTN)
U1111-1171-9367
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens discomfort 295003 0
Condition category
Condition code
Eye 295265 295265 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An intranasal lacrimal neurostimulator is a device (based on a standard TENS machine) used to deliver tiny electrical currents to the inner cavity of the nose, gently activating the nerves. Participants are instructed to place the tips of the device into both nostrils simultaneously. Nasoneurostimulation intensity is applied and controlled by pressing the plus (+) or minus (-) buttons on the device. Neurostimulation is applied for up to three minutes, until it can be felt that the eyes are watering and welling up (reflex tearing). The location of neurostimulation can be controlled by the depth and angle of insertion until a“tickle” sensation is experienced. Neurostimulation can be ceased by pressing the minus button on the device or by withdrawing the device from the nostrils. The device is applied 4 times daily (early morning, around lunchtime, late afternoon and before retiring to bed). This will occur for 5 consecutive days in week 1 or week 2 of the trial (Monday to Friday). The intervening two days (of the weekend) will serve as a wash-out period, during which contact lenses are not worn and the device is not applied. Adherence is monitored via text or email submissions daily from the participants.
Intervention code [1] 291816 0
Treatment: Devices
Intervention code [2] 292327 0
Prevention
Comparator / control treatment
Cross-over trial with device vs. standard treatment (use of artificial lubricant eye drops to relieve dry eye symptoms, as required)
Control group
Active

Outcomes
Primary outcome [1] 295013 0
Hours of comfortable contact lens wear, as advised by daily text or email to the researchers
Timepoint [1] 295013 0
Day 5 (Values recorded daily over 5 consecutive days)
Secondary outcome [1] 314579 0
Hours of total contact lens wear each day, as advised by daily text or email to the researchers
Timepoint [1] 314579 0
Day 5 (Values recorded daily over 5 consecutive days)
Secondary outcome [2] 314580 0
Number of rescue tear supplement drops required to be instilled to enable wear, as advised by daily text or email to the researchers
Timepoint [2] 314580 0
Day 5 (Values recorded daily over 5 consecutive days)

Eligibility
Key inclusion criteria
Contact lens wearers reporting end of day discomfort with regular soft contact lens wear
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non soft contact lens wearers
Contact lens wearers unwilling to wear a fresh pair of lenses at the start of each week
Evidence or history of ocular trauma, infection or surgery
Use of systemic medication that has altered in previous 3 months
Participation in a clinical trial within 3 months of current trial start date
Use of topical medications other than lubricant use for dry eye discomfort

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)
Subjects respond to adverts by contacting researchers. Participant information is provided and informed consent obtained. Allocation concealment is achieved by subjects being randomized to either the active or control arm during the first 5 days by centralized computer randomization prior to participant attendance. Two days washout is then followed with the alternative treatment/control during the next 5 days.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised number generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
Prospective, randomized
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/07/2015
Actual
23/07/2015
Date of last participant enrolment
Anticipated
30/09/2015
Actual
16/10/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 7026 0
New Zealand
State/province [1] 7026 0

Funding & Sponsors
Funding source category [1] 291613 0
Commercial sector/Industry
Name [1] 291613 0
Oculeve, Inc.
Country [1] 291613 0
United States of America
Primary sponsor type
Individual
Name
Associate Professor Jennifer P. Craig
Address
Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland 1042
Country
New Zealand
Secondary sponsor category [1] 290285 0
Commercial sector/Industry
Name [1] 290285 0
Oculeve Inc.
Address [1] 290285 0
2 Corporate Dr.
South San Francisco,
CA 94080

Country [1] 290285 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293147 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 293147 0
Ethics committee country [1] 293147 0
New Zealand
Date submitted for ethics approval [1] 293147 0
09/05/2015
Approval date [1] 293147 0
21/05/2015
Ethics approval number [1] 293147 0
UAHPEC 013299

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

Contacts
Principal investigator
Name 57066 0
A/Prof Jennifer P. Craig
Address 57066 0
Ocular Surface Laboratory
The University of Auckland
Private Bag 92019
Auckland
1142
Country 57066 0
New Zealand
Phone 57066 0
+6499238173
Fax 57066 0
Email 57066 0
jp.craig@auckland.ac.nz
Contact person for public queries
Name 57067 0
Jennifer P. Craig
Address 57067 0
Ocular Surface Laboratory
The University of Auckland
Private Bag 92019
Auckland
1142
Country 57067 0
New Zealand
Phone 57067 0
+6499238173
Fax 57067 0
Email 57067 0
jp.craig@auckland.ac.nz
Contact person for scientific queries
Name 57068 0
Jennifer P. Craig
Address 57068 0
Ocular Surface Laboratory
The University of Auckland
Private Bag 92019
Auckland
1142
Country 57068 0
New Zealand
Phone 57068 0
+6499238173
Fax 57068 0
+6493677173
Email 57068 0
jp.craig@auckland.ac.nz

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.