Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000367448
Ethics application status
Approved
Date submitted
27/09/2024
Date registered
24/04/2025
Date last updated
24/04/2025
Date data sharing statement initially provided
24/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the effect of Systane Hydration eye drops on corneal healing after photorefractive keratectomy laser eye surgery
Scientific title
Assessing the effect of Systane Hydration eye drops on corneal healing after transepithelial photorefractive keratectomy in individuals aged 18 to 50 years
Secondary ID [1] 313066 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry eye 335300 0
Corneal wound healing 335301 0
Transepithelial photorefractive keratectomy 335302 0
Condition category
Condition code
Eye 331877 331877 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of carboxymethylcellulose (comparator) & hyaluronic acid and hydroxypropyl guar (intervention) lubricating eyedrops as part of standard post-laser refractive eye surgery care.

All participants will be given two separate eyedrops unlabelled eye drops and are randomised and masked to which eye is receiving the intervention e.g. hyaluronic acid and hydroxypropyl guar (intervention) lubricating eyedrops and which eye is receiving the standard comparator (carboxymethylcellulose). Each bottle is labelled R and L for right and left eyes respectively and participants are told to administer one drop per eye, four times a day throughout the 30 day post-operative period. The eye drop treatment regime will commence on the same day as the laser eye surgery and used 4 times a day per eye at evenly spaced intervals. To ensure adherence to the protocol, the researcher who is also masked to the treatment will ensure that eye drops are being used correctly at the Day 1 and Day 3 post op review.
Intervention code [1] 329624 0
Treatment: Other
Comparator / control treatment
Carboxymethylcellulose lubricating eyedrops have been widely used as a treatment for dry eyes and as an extension of that as a standard treatment after laser refractive surgery. These drops are typically adminstered 1 drop per eye, 4 times a day to promote corneal wound healing after laser eye surgery. The eye drop treatment regime will commence on the same day as the laser eye surgery and used 4 times a day per eye at evenly spaced intervals. This will continue throughout the 30 day postoperative period.
Control group
Active

Outcomes
Primary outcome [1] 339488 0
The assessment of corneal wound healing after transepithelial photorefractive keratectomy will be measured using a series of markers. Therefore overall corneal wound healing will be assessed as a composite outcome.
Timepoint [1] 339488 0
Corneal wound healing will be assessed as a composite outcome at three time points: Pre-surgery, Day 3 and Day 30 post-surgery.
Primary outcome [2] 339489 0
Patient-reported outcome measure using a standardised dry eye grading scale known as the Ocular Surface Disease Index but modified to compare each eye as opposed to both eyes.
Timepoint [2] 339489 0
The patient reported outcomes will be assessed using the OSDI questionaire at three time points: Pre-surgery, Day 3 and Day 30 post-surgery.
Secondary outcome [1] 440185 0
Visual acuity
Timepoint [1] 440185 0
Visual acuity will be assessed using logMAR chart at three time points: Pre-surgery, Day 3 and Day 30 post-surgery.

Eligibility
Key inclusion criteria
Age: 18-50
Eligible for transepithelial photorefractive keratectomy
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No, this study compares the recovery after laser eye surgery, participants must have a refractive error to participate. Participants who are emmetropic (perfect vision) will be excluded from this study.

Participants who do not meet criteria for transepithelial photorefractive keratectomy or have a
prior history of ocular surgery, trauma or any existing eye conditions will also be excluded from this 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)
Allocation concealment was carried out using labelled containers for Right and Left eye. Participants remain unaware to which eyedrop is the treatment or comparator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eyes are randomly assigned to the treatment eyedrops using the excel rand() function, with the fellow eye assigned to the comparator eyedrops.
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
Other
Other design features
The new treatment will be compared against the comparator eye drop which is a more widely used formulation (regarded as 'standard' treatment) during the post-laser eye surgery recovery period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/07/2022
Date of last participant enrolment
Anticipated
Actual
15/08/2022
Date of last data collection
Anticipated
Actual
16/09/2022
Sample size
Target
50
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 317507 0
Commercial sector/Industry
Name [1] 317507 0
Alcon Laboratories (Australia) Pty Ltd
Country [1] 317507 0
Australia
Primary sponsor type
Individual
Name
Ben LaHood - Adelaide Eye & Laser (Level 1, 215 Greenhill Road Eastwood South Australia 5063)
Address
Country
Australia
Secondary sponsor category [1] 319804 0
Individual
Name [1] 319804 0
Jeremiah Lim - University of Western Australia, Department of Optometry and Vision Sciences, School of Allied Health (39 Fairway, Crawley WA 6009)
Address [1] 319804 0
Country [1] 319804 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316219 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 316219 0
Ethics committee country [1] 316219 0
Australia
Date submitted for ethics approval [1] 316219 0
01/04/2022
Approval date [1] 316219 0
24/06/2022
Ethics approval number [1] 316219 0
HREC 5380-4

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

Contacts
Principal investigator
Name 137190 0
Dr Jeremiah Lim
Address 137190 0
University of Western Australia, Department of Optometry and Vision Science, School of Allied Health (39 Fairway, Crawley WA 6009)
Country 137190 0
Australia
Phone 137190 0
+61 8 6488 7988
Fax 137190 0
Email 137190 0
[email protected]
Contact person for public queries
Name 137191 0
Ben LaHood
Address 137191 0
Adelaide Eye & Laser Centre (Level 1, 215 Greenhill Road Eastwood South Australia 5063)
Country 137191 0
Australia
Phone 137191 0
+61 8 8274 7000
Fax 137191 0
Email 137191 0
[email protected]
Contact person for scientific queries
Name 137192 0
Jeremiah Lim
Address 137192 0
University of Western Australia, Department of Optometry and Vision Science, School of Allied Health (39 Fairway, Crawley WA 6009)
Country 137192 0
Australia
Phone 137192 0
+61 8 6488 7988
Fax 137192 0
Email 137192 0
[email protected]

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


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.