Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000326392
Ethics application status
Approved
Date submitted
24/02/2017
Date registered
1/03/2017
Date last updated
1/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploring the benefits of a desktop humidifier for dry eye relief
Scientific title
Exploring the benefits of a desktop humidifier for dry eye relief
Secondary ID [1] 291266 0
None
Universal Trial Number (UTN)
U1111-1193-4589
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry eye 302198 0
Condition category
Condition code
Eye 301807 301807 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study location is the Ocular Surface Laboratory at the University of Auckland. On 2 separate days, with at least 24 hours washout between visits, participants are randomised to one hour of continuous computer use, with and without exposure to a desktop humidifier, set at a humidifying rate of 30ml/h (Homi Ltd). Environmental conditions are otherwise identical between the two scenarios. The humidifier placement remains identical throughout the experiment, at a distance of 70-75 cm from the eyes, and with the indicator light obscured.

Lipid layer grade, non-invasive tear film break-up time and tear meniscus height are measured by clinical researchers before and after computer use. Subjective comfort relative to baseline is also assessed following the 1-hour period.
Intervention code [1] 297275 0
Treatment: Devices
Comparator / control treatment
Control treatment is the identical scenario (1 hour of continuous computer use) without exposure to humidified air from the desktop humidifier. Participant is masked with respect to the activity or non-activity of the humidifier by occluding the indicator light on the humidifier, and with a low level humming noise that masks any sound from the humidifier. Participants were advised that vapour might or might not be visible in either scenario depending on the room conditions.
Control group
Placebo

Outcomes
Primary outcome [1] 301213 0
Non-invasive tear break up time (NIBUT) measured by observing mires reflected from the tear film after a blink for the first sign of a distortion in the pattern. The time between the blink and first distortion is recorded as the break up time and an average of three measurements is recorded.
Timepoint [1] 301213 0
After 1 hour exposure to continuous computer use
Secondary outcome [1] 332049 0
Lipid layer grade is evaluated by interferometry. Specular reflection of a wide-field white light on the surface of the tears highlights interference fringe patterns on biomicroscopic examination, that are graded according to thickness and quality.
Timepoint [1] 332049 0
After 1 hour of computer use
Secondary outcome [2] 332050 0
Subjective comparison of ocular comfort relative to baseline, following the one-hour period of computer use, using a force-choice, three-point scale: greater, equal or lesser comfort.
Timepoint [2] 332050 0
After 1 hour of computer use
Secondary outcome [3] 332051 0
Tear meniscus height: determined from a high magnification digital image that is subsequently calibrated via graticule on imaging software
Timepoint [3] 332051 0
After 1 hour of computer use

Eligibility
Key inclusion criteria
Age of 18 years or older
Non-contact lens wearers
No history of major systemic or ocular disease,
No history of ocular surgery, and
No use of topical or systemic medications known to affect the eye.
Able to provide written informed consent
Able to attend three visits on separate days
Presence or absence of dry eye symptoms
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 18 years of age
Contact lens wearers
History of major systemic or ocular disease,
History of ocular surgery, and
Current use of topical or systemic medications known to affect the eye

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)
Treatment order with active/inactive humidifier randomised centrally by computer and concealed from researcher enrolling participants and collecting outcome data. A third party individual sets up the participant in the treatment room with either the active or inactive device according to the treatment order that matches their enrolment number, as stated on the predetermined randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Selection of first exposure determined via random number generation. Consecutive participants exposed (odd number) or not exposed (even number) to humidifier at first visit. Alternative scenario presented at second visit
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Normally distributed continuous variables (relative humidity, temperature, tear meniscus height) between and within groups compared using paired t-tests. Non-normally distributed measures (NIBUT) logarithmically transformed before assessment by paired t-test. Ordinal data (lipid layer grade) analysed using Wilcoxon signed-rank tests. Categorical data (subjective comfort) compared using chi-squared tests or Fisher’s exact tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2010
Date of last participant enrolment
Anticipated
Actual
1/08/2010
Date of last data collection
Anticipated
Actual
3/08/2010
Sample size
Target
44
Accrual to date
Final
44
Recruitment outside Australia
Country [1] 8690 0
New Zealand
State/province [1] 8690 0
Auckland

Funding & Sponsors
Funding source category [1] 295721 0
University
Name [1] 295721 0
The University of Auckland
Country [1] 295721 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 294572 0
None
Name [1] 294572 0
Address [1] 294572 0
Country [1] 294572 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297023 0
The University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 297023 0
Ethics committee country [1] 297023 0
New Zealand
Date submitted for ethics approval [1] 297023 0
19/02/2010
Approval date [1] 297023 0
10/03/2010
Ethics approval number [1] 297023 0
6507

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

Contacts
Principal investigator
Name 72750 0
A/Prof Jennifer P Craig
Address 72750 0
Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland 1142
Country 72750 0
New Zealand
Phone 72750 0
+6499238173
Fax 72750 0
Email 72750 0
[email protected]
Contact person for public queries
Name 72751 0
Jennifer P Craig
Address 72751 0
Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland 1142
Country 72751 0
New Zealand
Phone 72751 0
+6499238173
Fax 72751 0
Email 72751 0
[email protected]
Contact person for scientific queries
Name 72752 0
Jennifer P Craig
Address 72752 0
Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland 1142
Country 72752 0
New Zealand
Phone 72752 0
+6499238173
Fax 72752 0
Email 72752 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.