None listed
Conditions
Brief 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.
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 b
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.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
- Healthy adult participants (18 years or older) - Normal eyelid architecture and closure
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
Outcome results
None listed