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Trial registered on ANZCTR


Registration number
ACTRN12625000294459p
Ethics application status
Submitted, not yet approved
Date submitted
4/04/2025
Date registered
14/04/2025
Date last updated
20/04/2025
Date data sharing statement initially provided
14/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative efficacy of artificial tears in the management of dry eye disease
Scientific title
Comparative efficacy of artificial tears in the management of dry eye disease
Secondary ID [1] 314001 0
None
Universal Trial Number (UTN)
U1111-1321-0438
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry eye disease 336804 0
Condition category
Condition code
Eye 333297 333297 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hylo Forte, Novatears, and Systane Complete preservative-free artificial tear drops will be the interventions used in this clinical trial. Each has different properties to provide either an aqueous or lipid-based supplementation to the ocular surface.
Hylo Forte artificial tears contain 2 mg/mL of sodium hyaluronate as the active ingredient and citric acid, sodium citrate dihydrate, and sorbitol as the inactive ingredients. NovaTears is a lipid-based artificial tear formulated from perfluorohexyloctane. Systane Complete contains propylene glycol, boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, sorbitan tristearate, and sorbitol. All participants will receive each intervention for three months. Participants will be randomly assigned to start one of the three interventions: Hylo Forte, Systane Complete or Novatears. They will be instructed to apply the assigned eye drops to both eyes four times a day for three months. After a two-week washout period to minimise carry-over effects, they will be crossed over, and each participant will proceed to the next assigned intervention. Participants will have a total of nine visits, with three visits scheduled during each treatment period: at baseline, one month, and three months. Participants will be provided with a physical diary to record details of artificial tear administration. The diary will include sections on the date and time of administration, the number of drops instilled, missed doses, symptoms or side effects, and any additional comments..
Intervention code [1] 330637 0
Treatment: Devices
Comparator / control treatment
The participants will act as their own controls as the trial is cross-over. Hylo Forte, an aqueous-based artificial tear, will be the reference comparator.
Control group
Active

Outcomes
Primary outcome [1] 340873 0
Ocular Surface Disease Index score (OSDI score)
Timepoint [1] 340873 0
Baseline, one month, and three months (primary endpoint) post-commencement of intervention.
Secondary outcome [1] 446036 0
MMP-9 Inflammatory biomarker
Timepoint [1] 446036 0
Baseline, one month, and three months post-commencemnt of intervention
Secondary outcome [2] 445535 0
Noninvasive tear break up time (NITBUT)
Timepoint [2] 445535 0
Baseline, one month, three months post-commencement of intervention
Secondary outcome [3] 446034 0
Ocular surface staining
Timepoint [3] 446034 0
Baseline, one month, and three months post-commencemnt of intervention.
Secondary outcome [4] 446033 0
Lipid layer thickness
Timepoint [4] 446033 0
Baseline, one month, and three months post-commencement of intervention
Secondary outcome [5] 446037 0
IL-6 inflammatory biomarker
Timepoint [5] 446037 0
Baseline, one month, and three months post-commencemnt of intervention
Secondary outcome [6] 446039 0
Corneal immune cell dynamics
Timepoint [6] 446039 0
Baseline, one month, and three months post-commencemnt of intervention

Eligibility
Key inclusion criteria
Age of 18 years and above
Have signs and symptoms of dry eye disease
Willing to use commercially available artificial tears
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active ocular infection, contact lens usage, intense pulse light therapy within 6 months, ocular surgery and trauma within three months, history of epilepsy or seizures, pregnancy or a plan to become pregnant within one year, and known hypersensitivity for components of Hylo Forte, Systane Complete, Novatears, fluorescein, and lissamine green dye will be excluded from the study.

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)
Active concealment will be done by removing the product label and applying an identifier code for each artificial tear bottle.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence randomisation will be used to allocate participants for each intervention.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data will be analysed by using Statistical Package for the Social Sciences (SPSS).
Primary analysis will be undertaken using ANOVA with factors of visits and treatment groups. Categorical data will be presented in frequency and percentage. Assumptions of normal distribution and constant variance will be verified. If necessary, data transformation will be carried out.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27669 0
School of Optometry and Vision Science - Kensington
Recruitment postcode(s) [1] 43844 0
2033 - Kensington

Funding & Sponsors
Funding source category [1] 318507 0
University
Name [1] 318507 0
University of New South Wales
Country [1] 318507 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 320896 0
None
Name [1] 320896 0
Address [1] 320896 0
Country [1] 320896 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317112 0
The University of New South Wales Committee C
Ethics committee address [1] 317112 0
Ethics committee country [1] 317112 0
Australia
Date submitted for ethics approval [1] 317112 0
27/02/2025
Approval date [1] 317112 0
Ethics approval number [1] 317112 0

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

Contacts
Principal investigator
Name 140034 0
A/Prof Maria Markoulli
Address 140034 0
School of Optometry and Vision Science, University of New South Wales Level 3 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 140034 0
Australia
Phone 140034 0
+612 9065 7355
Fax 140034 0
Email 140034 0
[email protected]
Contact person for public queries
Name 140035 0
Abel Sinshaw Assem
Address 140035 0
School of Optometry and Vision Science, University of New South Wales Level 3 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 140035 0
Australia
Phone 140035 0
+61400922529
Fax 140035 0
Email 140035 0
[email protected]
Contact person for scientific queries
Name 140036 0
Abel Sinshaw Assem
Address 140036 0
School of Optometry and Vision Science, University of New South Wales Level 3 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 140036 0
Australia
Phone 140036 0
+61400922529
Fax 140036 0
Email 140036 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24601Study protocol    Clinical Trial Protocol_Artificial tear.docx
24602Informed consent form    PISCF.docx


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.