None listed
Conditions
Brief summary
To assess bacterial contamination of regular lens cases when used in conjunction with investigational or marketed contact lenses on a daily wear schedule.
Interventions
Participants will be randomised into one of the two groups:
1.Commercially available NIGHT & DAY lenses with regular lens case
2.Investigational antibacterial lenses (AB lenses) with regular 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 and 4 months. Lens cases will be collected for microbiological analysis at 1 month and 4 months.
Sponsors
CIBA VISION
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
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; Be 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 corneal infection or 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; 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; 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