Trial Review

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
ACTRN12614000272695
Ethics application status
Approved
Date submitted
5/03/2014
Date registered
14/03/2014
Date last updated
29/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Stimulation Therapy versus Artificial Tears for the Treatment of Post-LASIK (laser in situ keratomileusis) Dry Eye
Scientific title
Neurostimulation versus Artificial Tears to Treat Post-LASIK Dry Eye in Adults Measured via Two Dry Eye Questionnaires
Secondary ID [1] 284204 0
Nil
Universal Trial Number (UTN)
U1111-1154-0722
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-LASIK dry eye 291310 0
Condition category
Condition code
Eye 291663 291663 0 0
Diseases / disorders of the eye
Eye 291664 291664 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 is self-administered nasally during waking hours. 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 every two to four hours. The duration of the intervention period is three months. The allocated treatment will commence two days prior to LASIK and continue post-LASIK.

Adherence to the intervention will be monitored by questioning of participants by study staff with responses recorded on case report forms.

Arm 2 – One drop of unpreserved artificial tears per eye to be self-administered during waking hours every two to four hours or as needed for a period of three months. The allocated treatment will commence two days prior to LASIK and continue post-LASIK.

Patient reports of their use of artificial tears are recorded on case report forms to monitor adherence to the intervention.
Intervention code [1] 288901 0
Treatment: Devices
Intervention code [2] 288917 0
Treatment: Other
Comparator / control treatment
Artificial tears
Control group
Active

Outcomes
Primary outcome [1] 291591 0
A comparison between groups in mean Ocular Surface Disease Index score
Timepoint [1] 291591 0
At 3 months after start of study treatment
Primary outcome [2] 291592 0
A comparison between groups in mean dry eye symptoms as assessed by a Visual Analogue Scale
Timepoint [2] 291592 0
At 3 months after start of study treatment
Secondary outcome [1] 307133 0
A comparison between groups in mean Schirmer test score
Timepoint [1] 307133 0
At 3 months after start of study treatment
Secondary outcome [2] 307134 0
A comparison between groups in mean corneal staining score
Timepoint [2] 307134 0
At 3 months after start of study treatment

Eligibility
Key inclusion criteria
Patients meeting all criteria for appropriateness of LASIK surgery instituted by the treating centre with an established date for bilateral primary LASIK surgery

Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol

Normal lid anatomy, blinking function and closure

Corrected visual acuity of 20/25 (Snellen equivalent) or better in each eye
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or electronic device

Diagnosed epilepsy with seizures within the past five years

Coagulation disorders such as haemophilia and thrombocytopenia

Active or uncontrolled severe systemic allergy, chronic seasonal allergies, rhinitis or sinusitis requiring treatment or active/untreated nasal infection at the time of the baseline examination

Punctal plugs

Contact lens wear during the study

Lacrimal, nasal or sinus neoplasia, significant trauma, or invasive surgery

Chronic or recurrent epistaxis, history of cocaine abuse, or Wegener’s granulomatosis

Participation in any clinical trial with a new active substance or a new device during the past three 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)
Consecutive patients will be randomly assigned using a random table of numbers. Allocation concealment will be accomplished by the use of sealed opaque envelopes.
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
Open (masking not used)
Who is / are masked / blinded?



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
1/04/2014
Actual
30/05/2014
Date of last participant enrolment
Anticipated
31/12/2014
Actual
24/09/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
51
Recruitment outside Australia
Country [1] 5865 0
Mexico
State/province [1] 5865 0
Baja California

Funding & Sponsors
Funding source category [1] 288828 0
Commercial sector/Industry
Name [1] 288828 0
Oculeve, Inc.
Country [1] 288828 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Oculeve, Inc.
Address
395 Oyster Point Boulevard
Suite 501
South San Francisco, CA 94080 USA
Country
United States of America
Secondary sponsor category [1] 287522 0
None
Name [1] 287522 0
Address [1] 287522 0
Country [1] 287522 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290668 0
CODET Vision Institute Comite de Investigacion y Etica
Ethics committee address [1] 290668 0
Ave Padre Kino 10159
Zona Rio, Tijuana, B.C. C.P. 22320
Ethics committee country [1] 290668 0
Mexico
Date submitted for ethics approval [1] 290668 0
10/03/2014
Approval date [1] 290668 0
20/03/2014
Ethics approval number [1] 290668 0

Summary
Brief summary
The purpose of this study is to evaluate dry eye symptoms and signs in patients having laser in situ keratomileusis (LASIK) randomized to receive either stimulation therapy or unpreserved artificial tears pre- and post-LASIK.
Trial website
Trial related presentations / publications
Not applicable.
Public notes

Contacts
Principal investigator
Name 46714 0
Dr Arturo Chayet
Address 46714 0
CODET Vision Institute
Av Padre Kino No. 10159
Zona Rio, Tijuana, BC 22320
Country 46714 0
Mexico
Phone 46714 0
+52 664 9792020
Fax 46714 0
+52 664 6824096
Email 46714 0
[email protected]
Contact person for public queries
Name 46715 0
Mr Mark Holdbrook
Address 46715 0
Oculeve, Inc.
395 Oyster Point Boulevard
Suite 501
South San Francisco, CA 94080 USA
Country 46715 0
United States of America
Phone 46715 0
+1 415 5806236
Fax 46715 0
+1 650 7370200
Email 46715 0
[email protected]
Contact person for scientific queries
Name 46716 0
Dr Arturo Chayet
Address 46716 0
CODET Vision Institute
Av Padre Kino No. 10159
Zona Rio, Tijuana, BC 22320
Country 46716 0
Mexico
Phone 46716 0
+52 664 9792020
Fax 46716 0
+52 664 6824096
Email 46716 0
[email protected]

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.