Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001173482
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
8/10/2025
Date registered
Help: Date registered
28/10/2025
Date last updated
Help: Date last updated
28/10/2025
Date data sharing statement initially provided
Help: Data sharing statement date
28/10/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase-I, randomised controlled trial (RCT) of Ultraviolet C (UVC) light therapy to assess ocular surface safety
Scientific title
Prospective, Phase-I, paired-eye, randomised controlled trial (RCT) assessing the safety of 5-seconds application Ultraviolet C (UVC) light therapy with PhotonUVC to the ocular surface in healthy adult participants
Additional trial identifiers [1] 315527 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Microbial keratitis 339131 0
Condition category
Condition code
Eye 335416 335416 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
A trained, unmasked clinician with more than 5 years clinical experience will use the small, handheld, non-contact PhotonUVC device to administer a single 5-second application of a low fixed dose (3.5 mW/cm²) of 265 nm Ultraviolet C (UVC) at the baseline visit to the ocular surface of either the right eye or the left eye, according to the randomization schedule, using the PhotonUVC device at the University of Auckland Eye Clinic. A masked clinician will assess ocular surface characteristics at baseline and repeat ocular surface evaluation and record reported tolerability at 15 minutes, 1 day, 1 week, and 1 month (primary timepoint) post-intervention for both eyes.
Intervention code [1] 332156 0
Treatment: Devices
Description of the comparator or control
The same trained, unmasked clinician will administer a single 5-second sham application (no UVC) to the contralateral eye at the baseline visit, according to the randomization schedule, using the Photon UVC device at the University of Auckland Eye Clinic. The masked clinician will assess ocular surface characteristics at baseline and repeat ocular surface evaluation and record reported tolerability at 15 minutes, 1 day, 1 week, and 1 month (primary timepoint) post-intervention for both eyes.
Control group
Placebo

Outcomes
Primary outcome [1] 342990 0
Change in corneal fluorescein staining
Timepoint [1] 342990 0
Baseline (prior to treatment), and 15 minutes, 1 day, 1 week and 1 month (primary timepoint) post application.
Secondary outcome [1] 453038 0
Change in best spectacle corrected distance visual acuity (BSCVA) in the treated eye
Timepoint [1] 453038 0
Baseline (prior to treatment), and 15 minutes, 1 day, 1 week and 1 month (primary timepoint) post-application.
Secondary outcome [2] 453039 0
Change in corneal optical density
Timepoint [2] 453039 0
Baseline (prior to treatment), and 1 day, 1 week and 1 month (primary timepoint) post-application.
Secondary outcome [3] 453040 0
Change in central corneal thickness
Timepoint [3] 453040 0
Baseline (prior to treatment), and 1 day, 1 week and 1 month (primary timepoint) post-application.
Secondary outcome [4] 453041 0
Change in intraocular pressure
Timepoint [4] 453041 0
Baseline (prior to treatment), and 1 day, 1 week and 1 month (primary timepoint) post-application.
Secondary outcome [5] 453042 0
Change in refractive error
Timepoint [5] 453042 0
Baseline (prior to treatment), and 1 day, 1 week and 1 month (primary timepoint) post-application.
Secondary outcome [6] 453043 0
Corneal topographic profile
Timepoint [6] 453043 0
Baseline (prior to treatment), and 1 day, 1 week and 1 month (primary timepoint) post-application.
Secondary outcome [7] 453044 0
Change in bulbar conjunctival hyperaemia
Timepoint [7] 453044 0
Baseline (prior to treatment), and 15 minutes, 1 day, 1 week and 1 month (primary timepoint) post-application.
Secondary outcome [8] 453045 0
Change in corneal aberrations
Timepoint [8] 453045 0
Baseline (prior to treatment) and 1 month (primary timepoint) post-application.
Secondary outcome [9] 453046 0
Corneal sensitivity
Timepoint [9] 453046 0
Baseline (prior to treatment), and 15 minutes, 1 day, 1 week and 1 month (primary timepoint) post-application.
Secondary outcome [10] 453049 0
Device application tolerability
Timepoint [10] 453049 0
15 minutes post-application

Eligibility
Key inclusion criteria
- Healthy adult participants (18 years or older)
- Normal eyelid architecture and closure
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
- Corrected visual acuity of less than 20/40 (LogMAR 0.5) in either eye.
- Any active or recent (in the last 3 months) ocular disease or conditions
- Signs of corneal dystrophy, previous trauma, corneal scarring
- Contact lens wear in the last 3 months or planned during the trial
- Use of eye drops in the last month or planned during the trial
- Pregnancy or lactation at the time of UVC application
- History of systemic disease
- Ocular surgery (e.g. refractive or cataract surgery) or light-based treatments (facial skin or eye) in the previous 3 months or planned during the study
- History of ocular or oral herpetic infections
- History or presence of any ocular disorder or condition in either eye that would likely interfere with the interpretation of the study results. This includes significant corneal or conjunctival scarring, pterygium or nodular pinguecula, current ocular infection or inflammation unrelated to dry eye, eyelid disorders, recurrent corneal erosions, known photosensitivity to light, etc
- Concurrent corticosteroid or other immunomodulatory treatment (systemic or topical)
- Concurrent potential immunosuppressive systemic disease
- Ocular discomfort score of greater than or equal to 13 on the Ocular Surface Disease Index questionnaire

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)
Treatment allocation occurs consecutively according to a predetermined randomisation schedule with treatment allocation concealed to all parties until device application time (via opaque concealed envelopes) to avoid risk of investigator influence in treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
Other
Other design features
Paired eye trial. One eye receives the active UVC application and the contralateral eye receives a sham (no UVC) application
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2025
Actual
Date of last participant enrolment
Anticipated
30/03/2026
Actual
Date of last data collection
Anticipated
30/04/2026
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment outside Australia
Country [1] 27423 0
New Zealand
State/province [1] 27423 0

Funding & Sponsors
Funding source category [1] 320127 0
Commercial sector/Industry
Name [1] 320127 0
Photon Therapeutics Ltd
Country [1] 320127 0
United Kingdom
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 322687 0
Commercial sector/Industry
Name [1] 322687 0
Photon Therapeutics Ltd
Address [1] 322687 0
Country [1] 322687 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318674 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 318674 0
Ethics committee country [1] 318674 0
New Zealand
Date submitted for ethics approval [1] 318674 0
27/11/2024
Approval date [1] 318674 0
09/06/2025
Ethics approval number [1] 318674 0
2025 EXP 21832

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

Contacts
Principal investigator
Name 144890 0
Prof Jennifer P Craig
Address 144890 0
Department of Ophthalmology, The University of Auckland, Private Bag 92019, Auckland 1142
Country 144890 0
New Zealand
Phone 144890 0
+6421853664
Fax 144890 0
Email 144890 0
[email protected]
Contact person for public queries
Name 144891 0
Jennifer P Craig
Address 144891 0
Department of Ophthalmology, The University of Auckland, Private Bag 92019, Auckland 1142
Country 144891 0
New Zealand
Phone 144891 0
+6421853664
Fax 144891 0
Email 144891 0
[email protected]
Contact person for scientific queries
Name 144892 0
Jennifer P Craig
Address 144892 0
Department of Ophthalmology, The University of Auckland, Private Bag 92019, Auckland 1142
Country 144892 0
New Zealand
Phone 144892 0
+6421853664
Fax 144892 0
Email 144892 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Not supported by data management conditions of ethical approval



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.