None listed
Conditions
Brief summary
This trial will examine the effect of a new solution on the ocular surface, subjective ocular comfort and anti-microbial efficacy of the new solution by lens case contamination. The hypotheses are these outcomes will be similar for each lens type and similar for published data on other solutions
Interventions
This is a prospective, bilateral, open-label, parallel group, daily wear (DW) study where 80 participants will be randomised to bilaterally wear either senofilcon A or lotrafilcon A contact lenses on a daily wear basis in conjunction with OPTI-FREE [Registered trade mark] EverMoist [Registered trade mark] multipurpose disinfecting solution (MPDS) for 3 months. There will be 5 scheduled visits: baseline, 2 hour visit, 2 week visit, 1 month visit and 3 month visit. These visits will involve asses
This is a prospective, bilateral, open-label, parallel group, daily wear (DW) study where 80 participants will be randomised to bilaterally wear either senofilcon A or lotrafilcon A contact lenses on a daily wear basis in conjunction with OPTI-FREE [Registered trade mark] EverMoist [Registered trade mark] multipurpose disinfecting solution (MPDS) for 3 months. There will be 5 scheduled visits: baseline, 2 hour visit, 2 week visit, 1 month visit and 3 month visit. These visits will involve assessment of visual acuity, ocular response by examination with a slit-lamp biomicroscope (a specialised microscope for viewing the eye) and assessment of ocular comfort using questionnaires employing a 1-10 numeric rating scale. Lenses will be worn a minimum of 5 days per week, 6 hours per day. EverMoist will be used after lens removal and as per manufacturer’s recommendation: Rub lenses with EverMoist (20 seconds), rinse lenses with EverMoist (10 seconds) and store in EverMoist for at least 6 hours. Solution is not to be re-used.
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. Be experienced or inexperienced at wearing contact lenses. Be able to insert and remove contact lenses. Be willing to not wear contact lenses for at least 48 hours before the commencement of the clinical trial (after informed consent).
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, 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 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. N.B.: 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 first 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* (either at enrolment or during the course of the trial). 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