None listed
Conditions
Brief summary
Lipids form an outer layer of the tear film, which is essential in retarding evaporation of the aqueous layer of the tears. Contact lenses, after being inserted onto the eye, adsorb tear lipids. Analysis of tear lipid changes before and after contact lens wear may reveal which lipid component causes problems (in terms of ocular discomfort and inflammatory responses) with contact lens wear. The study hypothesis is that contact lens wear and/or lens care solutions change the tear lipid profile and thereby influence lens performance.
Interventions
To investigate tear film lipid changes after contact lens wear and to correlate tear lipid changes after contact lens wear with lens performance. Participants will wear an Acuvue Oasys lens in one eye, comparing with the Purevision lens in the other eye. Participants will use one disinfection solution for the first month (randomised to either AoSept Plus or Optifree Replenish) and then cross over to the alternate disinfecting solution for the second month. Optifree Replenish (the intervention di
To investigate tear film lipid changes after contact lens wear and to correlate tear lipid changes after contact lens wear with lens performance. Participants will wear an Acuvue Oasys lens in one eye, comparing with the Purevision lens in the other eye. Participants will use one disinfection solution for the first month (randomised to either AoSept Plus or Optifree Replenish) and then cross over to the alternate disinfecting solution for the second month. Optifree Replenish (the intervention disinfection solution) is a multipurpose lens care solution which contains the antimicrobial agents polyquaternium-1 and myristamidopropyl dimethylamine. There will be a minimum of 2 calendar days (maximum 10 calendar days) wash-out period between the solution types.
Sponsors
Institute for Eye Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants enrolled in the trial must: Be 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; Be willing to comply with the wearing and 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; Have vision correctable to at least 6/12 (20/40) or better in each eye with contact lenses; Be experienced or may be inexperienced at wearing contact lenses.
Exclusion criteria
Participants enrolled in the trial must NOT have: Pre-existing ocular irritation that would preclude contact lens fitting; Known allergies to any of the ingredients in products tested; An ocular condition that may preclude safe wearing of contact lenses; An active corneal infection or any active ocular disease that would affect wearing of contact lenses; A need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial; Any systemic disease where fasting is contraindicated e.g. Type 1 diabetes, hypoglycaemia and any blood disorders (e.g. haemophilia) Any systemic disease that may affect ocular health. Conditions such as systemic hypertension do not automatically exclude prospective participants; Any systemic or topical medications up to 12 weeks prior to and during the trial that will affect ocular physiology or the performance of the lenses; Had eye surgery within 12 weeks immediately prior to enrolment for this trial; Undergone corneal refractive surgery; Any ocular injury or condition (including keratoconus, herpes keratitis and orthokeratology) of the cornea, conjunctiva or eyelids that would affect the wearing of contact lenses; Contraindications to contact lens wear; Currently enrolled in another clinical trial or participated in contact lens clinical trial within 2 weeks; Worn contact lenses for the past 2 weeks; Be pregnant. The Investigator may, at his/her discretion, exclude anyone else who they believe may not be able to fulfil the study requirements, or if it is believed to be in the participant’s best interests.
Outcome results
None listed