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Trial registered on ANZCTR


Registration number
ACTRN12619000275167
Ethics application status
Approved
Date submitted
20/02/2019
Date registered
25/02/2019
Date last updated
6/02/2020
Date data sharing statement initially provided
25/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Systane Complete versus saline on tear film properties in a symptomatic dry eye population
Scientific title
The effect of Systane Complete versus saline on tear film properties in a symptomatic dry eye population
Secondary ID [1] 297470 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry eyes 311661 0
Condition category
Condition code
Eye 310282 310282 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomized to receive either the test Systane Complete (HP-Guar and mineral oil) lubricant eye drops, one drop (approx 40uL) to be instilled in each eye four times daily for 4 weeks, or the control eye drop unit dose saline (0.9% sodium chloride), one drop (approx 40uL) to be instilled in each eye four times daily for 4 weeks. Participants will undergo a 4 week washout period before being crossed over to the alternate eye drop.
Adherence to treatment will be assessed by asking participants to return unused eye drop bottles and by questioning participants as to the average number of doses taken per day at the 4 week follow-up visit.
Intervention code [1] 313723 0
Treatment: Drugs
Comparator / control treatment
Unit dose saline (0.9% sodium chloride) four times daily for 4 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 319179 0
Non-invasive tear break-up time, measured in seconds using the Oculus Keratograph 5M
Timepoint [1] 319179 0
1 hour and 2 hours post-eye drop instillation after first use on day 1, and once after 4 weeks of daily use.
The primary endpoint is unknown and subject to investigation. However, appropriate statistical adjustments will be applied during the analysis to account for multiple comparisons.
Secondary outcome [1] 367185 0
Lipid layer thickness is measured in nanometres using the LipiView II Ocular Surface Interferometer
Timepoint [1] 367185 0
1 hour and 2 hours post-eye drop instillation after first use on day 1, and once after 4 weeks of daily use
Secondary outcome [2] 367186 0
Tear osmolarity is measured using the TearLab
Timepoint [2] 367186 0
1 hour and 2 hours post-eye drop instillation after first use on day 1, and once after 4 weeks of daily use
Secondary outcome [3] 367187 0
Tear evaporation rate is measured using a modified Vapometer
Timepoint [3] 367187 0
1 hour and 2 hours post-eye drop instillation after first use on day 1, and once after 4 weeks of daily use

Eligibility
Key inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
Adults aged 18 years and over with symptoms of dry eye;
Ocular Surface Disease Index score of greater than 12 at Screening (Visit 1);
Average lipid layer thickness less than or equal to 75nm in at least one eye at Screening;
Not wearing contact lenses for 1 month prior to the study and for the duration of the study;
Willing to use the study eye drops and refrain from using any other eye drops for the duration of the study;
Willing to refrain from using the study eye drops within 4 hours prior to each study visit;
Willing to comply with the study visit schedule and adhere to instructions as directed by the Investigator.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any active anterior segment disease excluding blepharitis;
Use of any of the following medications (including steroids) up to 12 weeks prior to start of the study or during the course of the study:
Ocular medication, category S3 and above;
Any systemic or topical medications that will affect ocular physiology e.g. anti-acne medications such as Roaccutane and corticosteroid or immunosuppressant medications such as Hydrocortisone, Prednisolone and antihistamine medications such as Claritine.
Use of any polyunsaturated fatty acid-containing dietary supplements (such as fish oil, evening primrose oil, linseed oil) for less than 12 weeks prior to the start of the study;
Planned changes to intake of polyunsaturated fatty acid-containing dietary supplements and/or diet (including typical intake of fish) for the duration of the study;
Use of any at-home eyelid warming treatments for less than 12 weeks prior to the start of the study, or planned changes to routine usage over the course of the study;
Use of any of the following dry eye treatments up to 6 months prior to the start of the study or during the course of the study:
o Intense Pulsed Light (IPL) therapy;
o Blephasteam;
o LipiFlow Thermal Pulsation treatment;
o Punctal plugs.
Any systemic disease that may affect ocular health e.g. Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis and systemic lupus erythematosus;
History of eye surgery within 6 months prior to enrolment in the study;
Epilepsy or history of migraines exacerbated by flashing, strobe-like lights;
Any known allergy to the ingredients in Systane Complete;
Pregnancy or breastfeeding.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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

Funding & Sponsors
Funding source category [1] 302039 0
Commercial sector/Industry
Name [1] 302039 0
Alcon Laboratories
Address [1] 302039 0
54 Waterloo Rd
Macquarie Park NSW 2113
Country [1] 302039 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Rupert Myers Building
Barker St.
Kensington NSW 2033
Country
Australia
Secondary sponsor category [1] 301843 0
None
Name [1] 301843 0
Address [1] 301843 0
Country [1] 301843 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302721 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 302721 0
Rupert Myers Building, South wing
Gate 14, Barker St.
UNSW Sydney
NSW 2052
Ethics committee country [1] 302721 0
Australia
Date submitted for ethics approval [1] 302721 0
20/02/2019
Approval date [1] 302721 0
02/04/2019
Ethics approval number [1] 302721 0
HC190126

Summary
Brief summary
This study aims to compare tear film properties including lipid layer thickness, tear osmolarity, tear evaporation rate and noninvasive tear breakup time up to 2 hours after instillation of Systane Complete (test eye drop) versus unpreserved unit dose saline (control), and after 4 weeks of daily use. Participants will be randomly assigned to receive either the test or control eye drop at the first visit. Tear film measurements including the thickness of the oily layer (lipid), stability (noninvasive tear break-up time and tear evaporation rate) and osmolarity (saltiness), and tear collection will be conducted at 1 hour and 2 hours post-eye drop instillation. Participants will be dispensed with this eye drop to be used four times a day until the 4 week follow-up visit. At the 4 week follow-up visit, measurements will be conducted again and the eye drops will be collected. Participants will undergo a 4 week washout period and then be crossed over to receive the alternate eye drop where the same procedures will be repeated as for the first eye drop. Participants will be dispensed with this second eye drop to be used four times a day until the 4 week follow-up visit. At the 4 week follow-up visit, measurements will be conducted again and the eye drops will be collected.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91158 0
Dr Jacqueline Tan-Showyin
Address 91158 0
School of Optometry and Vision Science
Rupert Myers Building, North wing
Gate 14, Barker St.
UNSW Sydney
NSW 2052
Country 91158 0
Australia
Phone 91158 0
+61 2 9385 6551
Fax 91158 0
Email 91158 0
jacqueline.tan@unsw.edu.au
Contact person for public queries
Name 91159 0
Dr Jacqueline Tan-Showyin
Address 91159 0
School of Optometry and Vision Science
Rupert Myers Building, North wing
Gate 14, Barker St.
UNSW Sydney
NSW 2052
Country 91159 0
Australia
Phone 91159 0
+61 2 9385 6551
Fax 91159 0
Email 91159 0
jacqueline.tan@unsw.edu.au
Contact person for scientific queries
Name 91160 0
Dr Maria Markoulli
Address 91160 0
School of Optometry and Vision Science
Rupert Myers Building, North wing
Gate 14, Barker St.
UNSW Sydney
NSW 2052
Country 91160 0
Australia
Phone 91160 0
+61 2 9385 9229
Fax 91160 0
Email 91160 0
m.markoulli@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results