A Phase-I, randomised controlled trial (RCT) of Ultraviolet C (UVC) light therapy to assess ocular surface safety
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
The University of Auckland
22 participants
Nov 1, 2025
Interventional
Conditions
Summary
This first-in-human clinical trial is designed to evaluate the safety and tolerability of a single 5-second Ultraviolet-C (UVC) exposure on the cornea using the PhotonUVC device (Photon Therapeutics Ltd, UK) in healthy participants. The study aims to generate robust scientific evidence regarding ocular surface safety as an initial step toward exploring the potential clinical application of UVC therapy for microbial keratitis.
Eligibility
Inclusion Criteria2
- Healthy adult participants (18 years or older)
- Normal eyelid architecture and closure
Exclusion Criteria13
- 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
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Interventions
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.
Locations(1)
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ACTRN12625001173482