None listed
Conditions
Brief summary
This study will examine whether a correlation exists between contamination of contact lens cases with Stenotrophomonas maltophilia and CIEs, when contact lenses and worn on a daily wear basis. The hypothesis is case contamination with Stenotrophomonas maltophilia does not correlate with CIEs.
Interventions
This is a prospective, single group, daily wear (DW) study where 90 participants will wear NIGHT & DAY [Registered trade mark] lenses bilaterally on a daily wear (DW) basis in conjunction with OPT-FREE [Trade mark] RepleniSH [Trade mark] solution for 4 months. There will be a minimum of 5 scheduled visits: baseline, 1 month visit, 2 month visit, 3 month visit and 4 month visit. These visits will involve assessment of visual acuity and examination with a slit-lamp biomicroscope (a specialised mic
This is a prospective, single group, daily wear (DW) study where 90 participants will wear NIGHT & DAY [Registered trade mark] lenses bilaterally on a daily wear (DW) basis in conjunction with OPT-FREE [Trade mark] RepleniSH [Trade mark] solution for 4 months. There will be a minimum of 5 scheduled visits: baseline, 1 month visit, 2 month visit, 3 month visit and 4 month visit. These visits will involve assessment of visual acuity and examination with a slit-lamp biomicroscope (a specialised microscope for viewing the eye). Lenses will be worn a minimum of 5 days per week, and 6 hours on the day lenses are worn.
Sponsors
Abbott Medical Optics, Inc
Study design
Allocation
Non-randomised trial
Intervention model
Single group
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 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 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 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 and at least 24 hours before study 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 study products; -Currently enrolled in another clinical trial. -Pregnancy: Formal testing of pregnancy is not required. A participant’s verbal report is sufficient -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.
Outcome results
None listed