None listed
Conditions
Brief summary
The aim of this study is to compare the accommodative lag response and accomodative adapation obatianed with different contact lens designs.
Interventions
Lotrafilcon B/ Asheric multifocal design contact lenses
Balafilcon A/ Asheric multifocal design contact lenses
Omafilcon A/Asheric multifocal design contact lenses
These lenses will be randomised to be worn for 8 days for each lens type. 4 visits (Baseline/Dispensing, interim visit 1 and 2 , Day 8 visit )are required for each lens type within the 8 day of lens wear. Minimum of 5 days of wash out period is required between different stages.
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 25 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 between the ages of 18 to 25 years of age, male or female. 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 a contact lens prescription that is myopic between -1.00 and -4.00D (inclusive). Have astigmatism that is not greater than -0.75DC and anisometropia between the two eyes of 1.00D or less. Is correctable to at least 6/9 (20/30) or better in each eye with contact lenses. Be an experienced and habitual contact lens wearer. Be able to insert and remove contact lenses.
Exclusion criteria
Any pre-existing ocular irritation, injury or condition (including infection or disease) 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 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. NB: Systemic antihistamines are allowed on an “as needed basis”, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used. Eye surgery within 12 weeks immediately prior to enrolment for this trial. Previous corneal refractive surgery. Contraindications to contact lens wear. Known allergy or intolerance to ingredients in any of the clinical trial products. 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. Pregnancy.
Outcome results
None listed