None listed
Conditions
Brief 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.
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 mo
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.
Sponsors
School of Optometry and Vision Science, University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Be at least 18 years of age; • An existing contact lens wearer (hydrogel or silicone hydrogel) not currently wearing daily disposable contact lenses; • Willing to wear the contact lenses on a daily wear basis for a minimum of 4 days per week (on average) for the duration of the study; • Willing to use the study prescribed contact lens case and disinfecting solution for the duration of the study.
Exclusion criteria
• Daily disposable or rigid gas permeable lens wearer (including ortho-keratology); • Non-contact lens wearer; • Self-reported metal/silver sensitivity/allergy; • Any active corneal infection, ocular disease or systemic disease that would affect wearing of contact lenses; • Use of or need for any systemic 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 risk providing a false positive; • Eye surgery within 12 weeks immediately prior to enrolment for this trial; • Contraindications to contact lens wear; • Currently enrolled in another clinical trial.
Outcome results
None listed