None listed
Conditions
Interventions
This is a prospective, bilateral, open-label, randomised clinical trial with participants wearing one of 4 commercially available contact lenses (AIR OPTIX [Trade mark] Aqua, NIGHT & DAY [Registered trade mark], ACUVUE OASYS [Trade mark], PureVision [Trade mark]) in conjunction with an investigational contact lens care solution over a 3 month period on a daily wear basis.
Participants will be randomised to wear one of 4 commercially available contact lenses. There are visits at 2 weeks, 1 month
This is a prospective, bilateral, open-label, randomised clinical trial with participants wearing one of 4 commercially available contact lenses (AIR OPTIX [Trade mark] Aqua, NIGHT & DAY [Registered trade mark], ACUVUE OASYS [Trade mark], PureVision [Trade mark]) in conjunction with an investigational contact lens care solution over a 3 month period on a daily wear basis. Participants will be randomised to wear one of 4 commercially available contact lenses. There are visits at 2 weeks, 1 month and 3 months from initial lens fitting. Contact lens cases will be collected at the 1 month and 3 months visits for analysis. each contact lens group will have a minimum of 40 participants.
Sponsors
Abbott Medical Optics, Inc
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
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 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; -Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses; -May be experienced or inexperienced at wearing contact lenses
Exclusion criteria
-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, Sjogrens 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 study; -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 manner or beneficial manner at enrolment and/or during the study; 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 or intolerance to ingredients in any of the study 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*; The Investigator may, at his/her discretion, exclude anyone 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