RecruitingACTRN12617001607369

Testing the ability of silver contact lens storage cases to control bacterial contamination

Study to evaluate the frequency of microbial contamination of silver versus non-silver contact lens storage cases in daily wear soft contact lens wear

Sponsor

School of Optometry and Vision Science, University of New South Wales

Enrollment

51 participants

Start Date

Jun 19, 2017

Study Type

Interventional

Conditions

Contact lens case contamination in asymptomatic contact lens wearer

Summary

The study aims to examine the rate and type of microbial contamination rate of silver impregnated and non-silver contact lens storage cases. This study is a prospective, randomized, double-masked, crossover clinical trial with three scheduled visits. A total 51 soft contact lens wearers will be recruited to use the silver impregnated lens cases and non-silver lens case (each for one month) along with a recommended multipurpose disinfecting solution. Participants will be allowed to use their existing lens brand. There will be total 3 visits within 2 months (baseline, 1st month and 2nd month). Routine assessment of contact lens fit and anterior eye health will be conducted at each visit and lens cases will be collected for microbial analysis at the 1st and 2nd month visits. At the end of 1st and 2nd month visits participants will be requested to complete a questionnaire relating to their contact lens use and we expect this activity will take approximately 20-30 minutes to complete. The contact lens case and solution will be provided free of charge during the study and at the end of 3rd study visit when the last lens case will be collected a replacement contact lens case will be provided. Participants will be provided with a $10 vouchers on 2nd and 3rd visits to compensate for their costs incurred in attending the study visits.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether contact lens storage cases with silver built into the plastic can kill more bacteria and keep the case cleaner compared to regular cases. Soft contact lens wearers will use both a silver case and a regular case for one month each, and the cases will be tested for bacteria at the end of each period. You may be eligible if: - You are aged 18 or older - You already wear soft (hydrogel or silicone hydrogel) contact lenses, but not daily disposables - You wear your lenses at least 4 days per week - You are willing to use the study-provided lens case and solution for 2 months You may NOT be eligible if: - You wear daily disposable lenses or rigid gas-permeable lenses - You have a known allergy or sensitivity to silver or metals - You have an active eye infection or disease affecting contact lens wear - You have had eye surgery within the past 12 weeks - You are currently enrolled in another clinical trial 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

The intervention being administered is silver-impregnated antimicrobial contact lens storage cases manufactured by Sauflon, UK (owned by CooperVision, CA, USA). After daily lens wear, participants will remove their contact lenses, clean them using the study provided multipurpose cleaning and disinfecting solution, and store their contact lenses in the experimental silver lens cases for overnight disinfection in the multipurpose solution. The experimental silver lens cases will be used for one month, and the order in which participants will be exposed to the experimental (and control) contact lens cases will be randomly assigned. The study contact lens storage cases will be distributed to participants for use at home, in plain unmarked study envelopes to maintain investigator masking. The used contact lens cases will be returned to the investigator after one-month and two-month at the scheduled follow-up visit.

Locations(1)

NSW, Australia

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ACTRN12617001607369