None listed
Conditions
Brief summary
To evaluate the on-eye performance of marketed contact lenses and contact lens solutions so as to evaluate which combinations perform best with each other
Interventions
Comparison of on-eye performance of marketed contact lenses to establish compatibility with commercially available lens care products (solutions). The comparison will involve evaluation of ocular health, lens performance on-eye and subjective responses with these lenses when used up to 3 months on a daily wear or extended wear and disposal schedule.
A range of 19 different contact lens brands (O2OPTIX [Trade mark], NIGHT & DAY, DAILIES AquaComfort Plus [Registered trade mark], ACUVUE ADVANCE [Tr
Comparison of on-eye performance of marketed contact lenses to establish compatibility with commercially available lens care products (solutions). The comparison will involve evaluation of ocular health, lens performance on-eye and subjective responses with these lenses when used up to 3 months on a daily wear or extended wear and disposal schedule. A range of 19 different contact lens brands (O2OPTIX [Trade mark], NIGHT & DAY, DAILIES AquaComfort Plus [Registered trade mark], ACUVUE ADVANCE [Trade mark], ACUVUE OASYS [Trade mark], ACUVUE 2 [Registered trade mark],1-DAY ACUVUE, 1-DAY ACUVUE. MOIST [Trade mark], Biofinity, Proclear, SofLens One Day, Biomedics One Day, Day by Day, Clear 1 Day, Gelflex 1 Day, PureVision [Trade mark], Avaira [Trade mark], AIR OPTIX [Trade mark], Aqua, AIR OPTIX Individual [Registered trade mark]),will each be combined with one of six different contact lens solutions (AOSept Plus, AQuify, ReNu MultiPlus, OPTI-FREE EXPRESS, OPTI-FREE RepleniSH, COMPLETE Multi-Purpose Solution Easy Rub [Trade mark] Formula). Each contact lens/solution combination will be administered to a minimum of 40 subjects who are involved in a trial for a period of 3 months. Within this 3 month period, each subject will be wearing only one contact lens brand and solution combination. There can be up to 50 different contact lens/solution combinations trialled over a 5 year period.
Sponsors
CIBA VISION
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
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 on a standard Bailey-Lovie logMAR distance letter chart (For a person to see 6/12 or better, this person needs to be able to distinguish clearly an object at 6 metres away that the 'average' person can distinguish at 12 metres away, 20/40 is the equivalent measurement in feet); - may be experienced or inexperienced at wearing contact lenses.
Exclusion criteria
Participants enrolled in the trial must NOT have: - Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses; - 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 erythematosis. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants; - A need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial; - 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; N.B. Systemic antihistamines are allowed on an ‘as needed basis’, provided they are not used prophylactically during the trial; - Eye surgery within 12 weeks immediately prior to enrolment for this trial; - Previous corneal refractive surgery; - Contraindications to contact lens wear; - Known allergy to ingredients in contact lens solutions; - Currently enrolled in another clinical trial; - Participation in a clinical trial within the previous 2 weeks or participation in an ‘inhouse’ clinical trial within the previous 48 hours; - Be pregnant* - Allergy or intolerance to topical anaesthetics 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. *Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.
Outcome results
None listed