None listed
Conditions
Brief summary
This study will examine the effect of a new solution on the ocular surface, subjective ratings of comfort and antimicrobial efficacy of the solution by lens-case examination. The hypotheses are these outcomes will be similar to historical control.
Interventions
This is a prospective, single group, daily wear (DW) study where 40 participants will wear PureVision[Registered trade mark] study lenses bilaterally on a daily wear (DW) basis in conjunction with Biotrue [Trade mark] solution for 3 months. There will be a minimum of 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, examination with a slit-lamp biomicroscope (a specialised microscope for viewing the e
This is a prospective, single group, daily wear (DW) study where 40 participants will wear PureVision[Registered trade mark] study lenses bilaterally on a daily wear (DW) basis in conjunction with Biotrue [Trade mark] solution for 3 months. There will be a minimum of 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, 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, 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. -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