Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000944336
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
16/07/2026
Date registered
Help: Date registered
30/07/2026
Date last updated
Help: Date last updated
30/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
30/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing smoke-Related Ocular injury through Targeted Eye Care sTrategies (PROTECT) in Australian bush firefighters
Scientific title
Preventing smoke related eye injury through topical ocular surface interventions in Australian bush firefighters
Additional trial identifiers [1] 317723 0
10383
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
dry eye disease 342612 0
Diseases / disorders of the eye 342613 0
ocular surface injury 342882 0
air pollution related ocular surface disease 342883 0
Condition category
Condition code
Eye 338765 338765 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
ARM 1: Povidone 0.68% and propylene glycol 0.3% in Rohto Dry Eye Aid eyedrops
Dose: One application (1–2 drops per eye) at least once during a single fireground shift. Participants may use additional applications during the shift as required according to symptoms.
Duration of treatment: Single fireground shift (one-day intervention).
Mode of delivery: Topical ophthalmic solution (eye drops).
Adherence: Participants will be instructed on correct use prior to the fireground shift. Adherence will be assessed using a post-shift questionnaire in which participants will report whether they used the eye drops and the number of applications during the shift.

ARM 2:
Not applicable. The intervention is a non-medicinal eyelid cleansing pad containing a proprietary surfactant-based cleansing formulation (not a medicinal active ingredient).
Dose: Clean the upper and lower eyelid margins of both eyes once during a single shift. Participants may use additional applications during the shift as required according to symptoms.
Duration of treatment: Single fireground shift (one-day intervention).
Mode of delivery: Topical eyelid cleansing using a pre-moistened disposable lid wipe.
Adherence: Participants will be instructed on the correct cleansing technique prior to the fireground shift. Adherence will be assessed using a post-shift questionnaire in which participants will report whether they used the lid wipe during the shift, and the number of applications during the shift and approximate time of usage.

ARM 3:
Sterile isotonic sodium chloride 0.9% solution
Dose: Rinsing one or both eyes at least once during a single fireground shift. Participants may use additional applications during the shift as required according to symptoms.

Duration of treatment: Single fireground shift (one-day intervention).

Mode of delivery: Topical ophthalmic solution (eye drops).

Adherence: Participants will be instructed on correct use prior to the fireground shift. Adherence will be assessed using a post-shift questionnaire in which participants will report whether they used the saline and the number of applications during the shift and approximate time of usage.
Intervention code [1] 334561 0
Treatment: Drugs
Intervention code [2] 334784 0
Treatment: Devices
Intervention code [3] 334785 0
Prevention
Description of the comparator or control
ARM 4 : Standard care - no intervention.
Participants allocated to standard care will not receive any study intervention products or specific advice regarding eye care. They may do whatever they would normally do for their eyes during fireground operations.
Control group
Active

Outcomes
Primary outcome [1] 346240 0
Ocular symptoms
Timepoint [1] 346240 0
Immediately before and after fireground shift and next day after fireground shift (8 - 12 hours after completing the shift)
Secondary outcome [1] 465142 0
Corneal sensitivity
Timepoint [1] 465142 0
Immediately before and after the fireground shift
Secondary outcome [2] 465144 0
Bulbar conjunctival redness
Timepoint [2] 465144 0
Immediately before and after the fireground shift
Secondary outcome [3] 465145 0
Palpebral conjunctival redness
Timepoint [3] 465145 0
Immediately before and after the fireground shift
Secondary outcome [4] 465146 0
Meibography
Timepoint [4] 465146 0
Immediately before and after the fireground shift
Secondary outcome [5] 465147 0
Fluorescein tear break up time (TBUT)
Timepoint [5] 465147 0
Immediately before and after fireground shift
Secondary outcome [6] 465148 0
Corneal vital staining
Timepoint [6] 465148 0
Immediately before and after fireground shift
Secondary outcome [7] 465150 0
Inflammatory profile of tear fluid
Timepoint [7] 465150 0
Immediately before and after fireground shift
Secondary outcome [8] 465152 0
Bulbar conjunctival cell sample collection
Timepoint [8] 465152 0
Immediately after fireground shift
Secondary outcome [9] 465398 0
Palpebral conjunctival roughness
Timepoint [9] 465398 0
Immediately before and after fireground shift
Secondary outcome [10] 465399 0
Bulbar conjunctival vital staining
Timepoint [10] 465399 0
Immediately and before fireground shift

Eligibility
Key inclusion criteria
Equal to or greater than 18 years of age
Employed or volunteer firefighters assigned fireground duties for at least 75% of their shift at controlled burns or bushfires
Expected operational deployment on the during the study period
Willing to comply with study protocol including download and using the mobile phone app called MyCap .
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Firefighters using contact lenses during their firefighting shift
Firefighters assigned non-fireground duties for >25% of their shift including but not limited to driving, aerial firefighting, command positions.
Allergy to menthol, castor or sesame oil
Allergy to sodium chloride

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)
Sealed opaque numbered envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random sequence,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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/08/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,WA,VIC

Funding & Sponsors
Funding source category [1] 322268 0
Other Collaborative groups
Name [1] 322268 0
Natural Hazards Research Australia
Country [1] 322268 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 325396 0
None
Name [1] 325396 0
Address [1] 325396 0
Country [1] 325396 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320785 0
The University of New South Wales Committee C
Ethics committee address [1] 320785 0
Ethics committee country [1] 320785 0
Australia
Date submitted for ethics approval [1] 320785 0
13/04/2026
Approval date [1] 320785 0
26/05/2026
Ethics approval number [1] 320785 0

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

Contacts
Principal investigator
Name 151618 0
Dr Sukanya Jaiswal
Address 151618 0
School of Optometry and Vision Science, Rupert Myers Building, University of New South Wales, 2052, NSW
Country 151618 0
Australia
Phone 151618 0
+61 2 9348 0540
Fax 151618 0
Email 151618 0
[email protected]
Contact person for public queries
Name 151619 0
Sukanya Jaiswal
Address 151619 0
School of Optometry and Vision Science, Rupert Myers Building, University of New South Wales, NSW 2052
Country 151619 0
Australia
Phone 151619 0
+61 2 9348 0540
Fax 151619 0
Email 151619 0
[email protected]
Contact person for scientific queries
Name 151620 0
Sukanya Jaiswal
Address 151620 0
School of Optometry and Vision Science, Rupert Myers Building, University of New South Wales, NSW 2052
Country 151620 0
Australia
Phone 151620 0
+61 2 9348 0540
Fax 151620 0
Email 151620 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: For ethical reasons, any data published will be aggregate only and in compliance with approved ethical requirements.



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.