None listed
Conditions
Interventions
5 Commercially available contact lenses (AIR OPTIX [Trade mark] Aqua, AIR OPTIX [Trade mark] Aqua Multifocal, NIGHT & DAY [Registered trade mark], ACUVUE 2 [Trade mark], Avaira [Trade mark])and 1 novel optical design silicone hydrogel contact lens have been chosen as test products to examine the effect of modulus and lens design on corneal topography after 1 week of wear. The novel optical design is manufactured from the same material as AIR OPTIX [trademark] Aqua and has a different optical pow
5 Commercially available contact lenses (AIR OPTIX [Trade mark] Aqua, AIR OPTIX [Trade mark] Aqua Multifocal, NIGHT & DAY [Registered trade mark], ACUVUE 2 [Trade mark], Avaira [Trade mark])and 1 novel optical design silicone hydrogel contact lens have been chosen as test products to examine the effect of modulus and lens design on corneal topography after 1 week of wear. The novel optical design is manufactured from the same material as AIR OPTIX [trademark] Aqua and has a different optical power distribution in the lens periphery. Contact lenses are suitable to be worn for 2 weeks, however, the 6 types of contact lenses will each be worn on a daily basis for approximately 1 week. Contact lens designs will be dispensed contralaterally by randomisation. Between each change of contact lens design contact lenses may not be worn for 1 calendar day, "1 day washout period", prior to each dispensing visit.
Sponsors
CIBA VISION Corporation
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
- be able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. If participant is a child or adolescent, a parent or legal guardian must be able to provide this consent, - be between the ages of 18 and 45 years old inclusive - be myopic (short sighted) -0.75D to -4.25D with astigmatism no more than -1.00 D - 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 wearing contact lenses
Exclusion criteria
- Pre-existing ocular irritation that would preclude contact lens fitting; - Strabismus or amblyopia; - Any ocular condition that may preclude safe wearing of contact lenses (e.g. active corneal infection, severe dry eye, reduced corneal sensitivity, exophthalmos/lagophthalmos, facial nerve palsy); - Active corneal infection (bacterial, viral, fungal or protozoan) or any active ocular disease such as iritis, corneal oedema or corneal dystrophies, including anterior membrane dystrophy that would affect wearing of contact lenses; - Any systemic disease that may adversely affect ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankolysing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosis. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants; - Eye surgery within 12 weeks immediately prior to enrolment for this trial; - Previous corneal refractive surgery; - Any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would affect the wearing of contact lenses; - Contraindications to hydrogel contact lens wear; - Worn orthokeratology lenses within the past 3 months; - Currently enrolled in another clinical trial; - Pregnancy (verbal report from participant will suffice).
Outcome results
None listed