None listed
Conditions
Brief summary
This study aims to determine the repeatability of an investigational instrument (Liquid Jet Aesthesiometer) and its application in contact lens related comfort. The instrument is used in optometric research to assess corneal sensitivity (i.e. measuring the smallest amount of stimulus for the anterior eye to detect sensation). To achieve this we wish to take measurements using the instrument over several days. Approximately 30 participants (15 contact lens wearers and 15 non-contact lens weares) will take part in each stage of the study. In Stage 1 of the study, we wish to assess the repeatability of the instrument in measuring corneal sensitivity over the course of 5 days. Once this stage is complete and pending data analysis of Stage 1 we may invite you to Stage 2, if you choose to participate, where we aim to assess the correlation between corneal sensitivity measurements and comfort over the course of 3 days. You do not have to participate in both stages of the study.
Interventions
This is an observational study. The study consists of two stages. In the first stage, corneal sensitivity will be measured using the liquid jet aesthesiometer in participants over 5 days at similar time points over the 5 days. The liquid jet aesthesiometer uses tiny droplets of saline of variable size to generate a mechanical stimulus on the cornea without inducing a thermal component. Using a staircase method, participants will respond with a can or can't feel response to determine corneal sens
This is an observational study. The study consists of two stages. In the first stage, corneal sensitivity will be measured using the liquid jet aesthesiometer in participants over 5 days at similar time points over the 5 days. The liquid jet aesthesiometer uses tiny droplets of saline of variable size to generate a mechanical stimulus on the cornea without inducing a thermal component. Using a staircase method, participants will respond with a can or can't feel response to determine corneal sensitivity threshold. In the second stage, corneal sensitivity and subjective ocular comfort ratings will be collected in the morning and afternoon (2 visits separated 6 hours apart) over 3 separate days. Ocular comfort ratings will be collected via a questionnaire prior to corneal sensitivity measurements using the Liquid Jet Aesthesiometer.
Sponsors
Brien Holden Vision Institute
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. Be at least 18 years old, male or female. Willing to comply with the clinical trial visit schedule as directed by the Investigator. Have ocular health findings considered to be “normal” and which would not prevent the participant from safely wearing contact lenses. Be experienced soft contact lens wearers or inexperienced with contact lenses.
Exclusion criteria
Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would affect corneal sensitivity. Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants. Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial. Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial. Eye surgery within 12 weeks immediately prior to enrolment for this trial. Previous corneal refractive surgery. Previous rigid gas permeable (RGP) or Orthokeratology lens wear Currently enrolled in another clinical trial. Participation in a clinical trial within the previous 2 weeks for dispensing studies and 48 hours between in-house studies.
Outcome results
None listed