RecruitingACTRN12609000067279

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.


Sponsor

CIBA VISION

Enrollment

80 participants

Start Date

Feb 14, 2009

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether contact lens cases become contaminated with bacteria during normal daily wear of either new (investigational) or currently available contact lenses. Bacterial contamination of lens cases is a known risk factor for eye infections. By tracking how quickly bacteria build up in cases under normal use, researchers hope to improve guidance on contact lens safety and hygiene. You may be eligible if: - You are at least 18 years old - You can read and understand English and provide informed consent - You are willing to attend study visits and follow the wearing schedule - Your eyes are generally healthy for wearing contact lenses - Your vision can be corrected to at least 6/12 (20/40) with contact lenses You may NOT be eligible if: - You have an existing eye irritation, injury, or condition that prevents safe contact lens wear - You have a systemic disease that affects eye health - You have an active eye infection - You are taking eye medications (Category S3 and above) within 12 weeks before or during the trial - You have had corneal refractive surgery (e.g., LASIK) - You are currently enrolled in another clinical trial - You are pregnant Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 c

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)

Australia

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ACTRN12609000067279