Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001737820
Ethics application status
Approved
Date submitted
18/11/2021
Date registered
20/12/2021
Date last updated
2/12/2022
Date data sharing statement initially provided
20/12/2021
Date results information initially provided
2/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in corneal epithelial irregularity following treatment with artificial tears in a symptomatic dry eye population
Scientific title
Changes in corneal epithelial irregularity following treatment with artificial tears in a symptomatic dry eye population
Secondary ID [1] 305837 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry eye 324371 0
Condition category
Condition code
Eye 321857 321857 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Commercially available, over-the-counter eye drops:
1. Systane Hydration
2. Hylo-Forte
One drop to be instilled in each eye four times daily for 4 weeks.
Participants will be randomly allocated to one of the two study eye drops, or the control treatment (saline) in an equal 1:1:1 ratio, in this parallel group study.
The assigned study eye drops will be instilled in both eyes by participants.
Compliance to treatment will be determined via verbal confirmation at each follow-up visit.
Intervention code [1] 322238 0
Treatment: Drugs
Comparator / control treatment
Unpreserved unit dose saline (0.9% sodium chloride).
Participants will be randomly allocated to the study eye drops, and have an equal chance of receiving one of the two treatment eye drops or the control in this parallel group study.
The assigned eye drops will be instilled in both eyes by participants - one drop in each eye four times daily for 4 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 329616 0
Change in corneal epithelial irregularity factor (EIF). Epithelial thickness will be measured using the Optical Coherence Tomographer and the EIF calculated as previously described in the literature (Abou Shousha et. al. Eye (2020) 34:915-922).
Timepoint [1] 329616 0
The primary timepoint is 2 weeks after starting the treatment.
Follow-up visits are planned at 48 hours, 2 weeks and 4 weeks after starting treatment.
Secondary outcome [1] 403172 0
Ocular Surface Disease Index Score
Timepoint [1] 403172 0
Up to 4 weeks after starting treatment.
Follow-up visits are planned at 48 hours, 2 weeks and 4 weeks after starting treatment.
Secondary outcome [2] 403173 0
Fluorescein corneal staining will be used to evaluate the integrity of the corneal surface.
Timepoint [2] 403173 0
Up to 4 weeks after starting treatment.
Follow-up visits are planned at 48 hours, 2 weeks and 4 weeks after starting treatment.

Eligibility
Key inclusion criteria
• Aged 18 years or older;
• Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
• Minimum of 6 months since onset of self-reported dry eye;
• Ocular Surface Disease Index score (OSDI) of >23 or Oxford Corneal Staining score 2 or 3 in at least one eye at Screening (Visit 1);
• Not wearing soft contact lenses for 1 month prior to the study and for the duration of the study;
• Willing to use the study eye drops four times daily for the duration of the study;
• Been on stable dry eye treatment for at least 60 days prior to the study and willing to refrain from using any other topical eye drops apart from the study eye drops for the duration of the trial;
• Willing to refrain from using warm compress treatments for dry eye for the duration of the trial;
• Willing to refrain from using any eye drops on the same day as the first study visit, and within 2 hours of each study visit;
• All prescription medications have been used consistently for at least 3 months prior to the study, and no planned changes for the duration of the trial;
• No significant changes to diet implemented within 3 months prior to the first visit;
• No planned changes to diet and willing not to substantially alter their usual diet for the duration of the study, including use of any polyunsaturated fatty acid-containing dietary supplements (such as fish oil, evening primrose oil, linseed oil);
• 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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Any active anterior segment disease;
• Corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or corneal integrity;
• Patients who are currently using topical ocular medication or have used topical ocular medication within 12 weeks of the first visit;
• Any known allergy to the study eye drops;
• 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 corneal eye infection or any eye surgery;
• Gas permeable contact lens wearer (including ortho-k) within 6 months of the first visit;
• 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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed model analysis will be used. The p value is set at p<0.05. Bonferroni adjustment will be used for multiple comparisons.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/01/2022
Actual
11/04/2022
Date of last participant enrolment
Anticipated
23/05/2022
Actual
26/07/2022
Date of last data collection
Anticipated
30/06/2022
Actual
26/08/2022
Sample size
Target
48
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 35995 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 310194 0
Commercial sector/Industry
Name [1] 310194 0
Alcon Laboratories
Country [1] 310194 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Rupert Myers Building
Gate 14, Barker St.
UNSW Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 311281 0
None
Name [1] 311281 0
Address [1] 311281 0
Country [1] 311281 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309874 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 309874 0
Rupert Myers Building, South wing
Gate 14, Barker St.
UNSW Sydney NSW 2052
Ethics committee country [1] 309874 0
Australia
Date submitted for ethics approval [1] 309874 0
22/11/2021
Approval date [1] 309874 0
01/03/2022
Ethics approval number [1] 309874 0

Summary
Brief summary
The research study aims to evaluate the effect of two different commercially available eye drops on the outermost layer (epithelium) of the cornea (clear, front surface of the eye), compared to saline, in subjects with dry eye. The corneal epithelium is more irregular in subjects with dry eye compared to non-dry eye populations. Therefore, this study will investigate whether the study eye drops improve corneal epithelial irregularity and how quickly this occurs following treatment.. Participants will be randomly allocated (like flipping a coin) to the eye drops to be used in this study four times daily. Assessments will be conducted 48 hours, 2 weeks and 4 weeks after the study eye drops are dispensed. Subjective comfort will also be measured before and at each follow-up visit using questionnaires. The primary timepoint is 2 weeks, but outcomes up to 4 weeks after starting treatment, including the 48 hour timepoint, will be analysed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115690 0
Dr Jacqueline Tan-Showyin
Address 115690 0
School of Optometry and Vision Science
Level 3, Rupert Myers Building, North wing
Gate 14, Barker St.
UNSW Sydney NSW 2052
Country 115690 0
Australia
Phone 115690 0
+61 29385 6551
Fax 115690 0
Email 115690 0
jacqueline.tan@unsw.edu.au
Contact person for public queries
Name 115691 0
Ms Katherine Wong
Address 115691 0
School of Optometry and Vision Science
Level 3, Rupert Myers Building, North wing
Gate 14, Barker St.
UNSW Sydney NSW 2052
Country 115691 0
Australia
Phone 115691 0
+61 29065 1248
Fax 115691 0
Email 115691 0
katherine.y.wong@unsw.edu.au
Contact person for scientific queries
Name 115692 0
Dr Jacqueline Tan-Showyin
Address 115692 0
School of Optometry and Vision Science
Level 3, Rupert Myers Building, North wing
Gate 14, Barker St.
UNSW Sydney NSW 2052
Country 115692 0
Australia
Phone 115692 0
+61 29385 6551
Fax 115692 0
Email 115692 0
jacqueline.tan@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
Data sharing is subject to approval by ethics and the funding body


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.