None listed
Conditions
Brief summary
hypotheses for this study include: Study hypothesis is that antibacterial lens cases will have less contamination inside the lens storage case than a regular lens case. Primary purpsoe of the study is to assess bacterial contamination of antibacterial contact lens cases when used in conjunction with marketed contact lenses worn on a daily wear and monthly replacement schedule and to compare the results to a historical control.
Interventions
All participants will be dispensed with commercially available Purevision (balafilcon A) lenses with antibacterial lens case. Participants will wear lenses on a daily wear (ie. not sleeping in the lenses) basis for 4 months. Lens performance will be assessed at the baseline visit, and after 2 weeks, 1 month, 3 months and 4 months. Lens cases will be collected for microbiological analysis at the monthly visits. All participants will use the same brand of lenses and antibacterial lens case
Sponsors
Institute for Eye Research
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Be 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; Be 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 may be inexperienced at wearing contact lenses
Exclusion criteria
Pre-existing ocular irritation, injury or condition that would preclude contact lens fitting and safe wearing of contact lenses; Any systemic disease that adversely affects ocular health; any active ocular disease that would affect wearing of contact lenses; A need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial; 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; Eye surgery within 12 weeks immediately prior to enrolment for this trial; Previous corneal refractive surgery; Contraindications to contact lens wear; Currently enrolled in another clinical trial; Participation in a clinical trial within the previous 2 weeks for dispensing studies; Allergy or intolerance to silver; Pregnant women are excluded from the trial - formal testing of pregnancy is not required. A participant's verbal report is sufficient.
Outcome results
None listed