None listed
Conditions
Brief summary
This study is investigating whether ‘time of day’ factors and sleep patterns affect immune cells (cells that protect the eye) in the cornea (transparent front part of the eye). This study will also examine whether different light filtering lenses (that block different wavelengths of light) influence the behaviour of corneal immune cells. The study will aim to enrol 24 participants, with a target of 18 completed participants, aged 18 to 45 years, who have healthy eyes and do not regularly wear contact lenses or spectacles for daily activities. Participants will attend for 8 study visits in total, comprising 3 visits in the morning (08:00 AM-10:00 AM) and 5 visits in the late afternoon (16:00 PM-18:00 PM). Over the course of the study, participants will be asked to wear various forms of eye wear, consisting of an eyepatch and safety glasses with a filtered lens over one eye, overnight and/or throughout the day, as directed by the study team, as well as have some tear and blood samples collected.
Interventions
The eye exposed to the intervention will be randomly allocated. Each intervention will be worn once only, as described for each intervention (below).
• Nexcare Opticlude Orthoptic Eyepatch
The Nexcare Opticlude Eyepatch will be worn overnight over one eye until the next morning visit (08:00-10:00).
On a separate testing day, about one week later, the Nexcare Opticlude Eyepatch will be worn overnight over one eye until the next late afternoon visit (16:00-18:00).
• NOIR Frame style #46 Laser Sa
The eye exposed to the intervention will be randomly allocated. Each intervention will be worn once only, as described for each intervention (below). • Nexcare Opticlude Orthoptic Eyepatch The Nexcare Opticlude Eyepatch will be worn overnight over one eye until the next morning visit (08:00-10:00). On a separate testing day, about one week later, the Nexcare Opticlude Eyepatch will be worn overnight over one eye until the next late afternoon visit (16:00-18:00). • NOIR Frame style #46 Laser Safety Eyewear for 180-532nm, Filter colour: orange, Visible Light Transmission: 48%, CE rating/EN207 180-315, D LB7 + IR LB4, >315-532 DIRM LB6 (Blue + UV filter) On a separate week, the NOIR safety glasses with Blue + UV filter over one eye (control eye exposed to natural light) will be worn from awakening until a visit in the late afternoon (16:00-18:00). • NOIR Frame style #46 Laser Safety Eyewear for 190-398nm and 10,600nm, Filter colour: clear, Visible Light Transmission: 93%, CE rating 190-315 D LB7 + IR LB4, >315-398 DIRM LB5, 9000-11000 DI LB3 (UV only filter) On a separate week, the NOIR safety glasses with UV- only filter will be worn over one eye (with the control eye exposed to natural light) from awakening in the morning, until late in the late afternoon (16:00-18:00). A reminder notification to use the intervention, as indicated, will be sent out to participants the day prior to the study visit. Adherence to the intervention will be assessed by participant self-report at the study visit.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
• Male or female aged 18 to 45 years, with full legal capacity to volunteer; • Provide written informed consent to participate; • In good general health; • Have the ability to understand and follow study instructions, with the intention of completing all required study visits; • Have not worn contact lenses consistently (i.e., less than once per week) over the three months prior to baseline; • Habitual unaided monocular distance vision (uncorrected distance visual acuity) of at least 6/15 or binocular 6/12, and unaided binocular near vision of N12 or better at 40cm; • Have typical sleeping patterns, defined as obtaining at least six hours of sleep per night, with sleep onset time between 21:00 PM and 2:00 AM, and waking up between 05:00 AM and 09:00 AM; • Have at least 3 T cells in either the corneal whorl or periphery within the field of view on IVCM at baseline.
Exclusion criteria
• Any known active ocular disease and/or infection (including dry eye disease). • Presence of any of the following conditions: active ocular inflammation, active ocular allergy, a corneal disorder or abnormality that could affect corneal sensitivity or normal spreading of the tear film (except superficial punctate keratitis), severe blepharitis or obvious inflammation of the eyelid margin, which in the judgment investigator may interfere with the interpretation of the study results. • An injury to either eye in the 12 weeks prior to enrolment. • Ocular surgery within the past six months at baseline, or has ocular surgery planned over the course of participation in the study. • Prior history of laser refractive eye surgery. • A known allergy to, or previous reaction to, any eye drops required for the study. • The presence of significant corneal scarring or a physical factor that impairs the ability to perform corneal imaging. • Clinically significant dry eye disease, as specified in the Tear Film and Ocular Surface Society Dry Eye Workshop II (TFOS DEWS II) definition, defined by dry eye symptoms (i.e., an Ocular Surface Disease Index (OSDI) score greater than or equal to 13, out of 100 (Schiffman et al. 2000)) AND one or more of the following clinical signs (Wolffsohn et al. 2017): o Tear osmolarity of greater than or equal to 308 mOsm/L in either eye or interocular differences greater than 8mOsm/L; o Tear break up time (TBUT) < 10 sec in either eye; o Ocular surface staining: > 5 corneal spots, > 9 conjunctival spots, or lid margin (greater than or equal to 2 mm length and greater than or equal to 25% width) • Current use of any topical medications other than artificial lubricant eye drops (e.g., anti-glaucoma medications, corticosteroids); • Have a history of a systemic infection known to affect corneal immune status (e.g., positive for COVID-19 or upper respiratory infection within 4 weeks of baseline), by self-report; • Have received a vaccination within 2 weeks of baseline, by self-report; • Any condition that would contraindicate the drawing of blood, or a significant history of vasovagal syncope during blood draws; • Any blood-borne illnesses such as hepatitis and Human Immunodeficiency Virus (HIV) that may affect the eyes • Females who are pregnant or breastfeeding at the time of study enrolment or who plan to become pregnant during the study (as reported by the participant); • Unable or unwilling to wear the study interventions (eye patch, blue + UV light-filtering glasses, and UV only light-filtering glasses) or an actigraphy watch and MiEye light meter ‘pin’, as assessed during the Baseline visit; • Unable or unwilling to keep a sleep diary; • Requires a habitual spectacle or contact lens correction for daily activity; • Unable to sit/lie supine comfortably during the examination procedures. • Participation in an interventional clinical trial within the previous 30 days, or currently enrolled in an interventional clinical trial; • Current shift-work and/or recent cross-time zone travel in the last month, or such anticipated travel during the study period; • A condition or situation that, in the opinion of the study investigator, will limit the potential participant’s ability to comply with the study protocol, might adversely affect their safety or substantially confound the study outcomes. References: 1. Schiffman, R.M., et al., Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol, 2000. 118(5): p. 615-21. 2. Wolffsohn, J.S., et al., TFOS DEWS II Diagnostic Methodology report. Ocul Surf, 2017. 15(3): p. 539-574.
Outcome results
None listed