None listed
Conditions
Brief summary
This trial will examine the effect of a new solution on subjective response, the ocular surface, and lens deposition. The hypotheses are these outcomes will be similar for each lens type and similar for control solutions
Interventions
This is a prospective, open label clinical trial with two parallel groups of 40 participants each, randomised to ACUVUE [Registered trade mark] OASYS [Trademark] or ACUVUE [Registered trade mark] 2 lenses worn bilaterally for one month on a daily-wear basis (n=80 in total). Each lens-group will be, randomised to COMPLETE [Registered trade mark] Multi-Purpose Solution Easy Rub [Trademark] Formula or renu [Registered trade mark] fresh [Trademark] for the first month of the trial only (n=20 in e
This is a prospective, open label clinical trial with two parallel groups of 40 participants each, randomised to ACUVUE [Registered trade mark] OASYS [Trademark] or ACUVUE [Registered trade mark] 2 lenses worn bilaterally for one month on a daily-wear basis (n=80 in total). Each lens-group will be, randomised to COMPLETE [Registered trade mark] Multi-Purpose Solution Easy Rub [Trademark] Formula or renu [Registered trade mark] fresh [Trademark] for the first month of the trial only (n=20 in each solution / lens combination). After the first month of lens wear, all participants will be crossed over into Topaz multipurpose solution, whilst continuing wear of the same lens type. Lenses will be worn on a daily-wear basis for a further three months. There will be four scheduled visits: baseline, 1-month visit, 2-month visit, 4-month visit. These visits will involve assessment of visual acuity, assessment of ocular comfort using questionnaires employing a 1-10 numeric rating scale and ocular response by examination with a slit-lamp biomicroscope (a specialised microscope for viewing the eye) . Lenses will be worn a minimum of 5 days per week, 6 hours per day. All solutions will be used after lens removal and as per manufacturer’s recommendation: Rub lenses with solution (5 seconds), rinse lenses with solution (5seconds) and store in solutionfor at least 6 hours. Solution is not to be reused. Contact lenses will be replaced 2x/month.
Sponsors
Abbott Medical Optics, Inc
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 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. Be an experienced 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. Neophytes (potential Participants who have not previously worn contact lenses). 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 clinical trial requirements or 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