Bacterial contamination of regular contact lens cases during daily wear of marketed and investigational contact lenses.
Prospective, parallel-group, randomised, open label, bilateral daily wear study to investigate bacterial contamination of regular contact lens cases when used in conjunction with marketed and investigational contact lens.
CIBA VISION
80 participants
Feb 14, 2009
Interventional
Conditions
Summary
To assess bacterial contamination of regular lens cases when used in conjunction with investigational or marketed contact lenses on a daily wear schedule.
Eligibility
Inclusion Criteria6
- 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 Criteria10
- 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.
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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.
Locations(1)
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ACTRN12609000067279