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, single-masked, crossover clinical trial with five scheduled visits. A total 40 soft contact lens wearers will be recruited to use the silver impregnated lens cases and non-silver lens case (each for three month) along with a multipurpose disinfecting solution. Participants will be allowed to use their existing lens brand. There will be total 5 visits within 6 months (baseline, 1 month, 3 months, 4 month and 6 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 1, 3, 4 and 6 month visits. At each visit, participants will be requested to complete two questionnaires relating to their contact lens use. The contact lens storage cases and multi-purpose disinfecting solutions will be provided free of charge during the duration of the study. Participants will be provided with a $10 vouchers at the end of each study visit to compensate for their costs incurred in attending the study visits.
Interventions
Silver-impregnated antimicrobial contact lens storage cases (Test) and HyCare multipurpose disinfecting solution (MPDS) manufactured by CooperVision, CA, USA will be used. Participants will use the lens storage cases and MPDS for a total of 3 months. The order in which participants will be exposed to the test and control contact lens storage cases will be randomised. Contact lens storage case will used for 1 month and returned at the 1-month (1 case) and 3-month (2 cases) follow-up visit. Part
Silver-impregnated antimicrobial contact lens storage cases (Test) and HyCare multipurpose disinfecting solution (MPDS) manufactured by CooperVision, CA, USA will be used. Participants will use the lens storage cases and MPDS for a total of 3 months. The order in which participants will be exposed to the test and control contact lens storage cases will be randomised. Contact lens storage case will used for 1 month and returned at the 1-month (1 case) and 3-month (2 cases) follow-up visit. Participants will be provided with labelled sealable plastic bags to store their 1-month used contact lens storage cases and MPDS bottles. Participants will be required to start using a new pair of their habitual contact lenses at commencement of the study. They will have to wear their contact lenses for at least 4 days a week on average for the duration of the study and to replace their contact lenses according to the manufacturer’s recommended schedule. Participants will be advised to wash and dry their hands with soap prior to handling contact lenses and storage cases. Following contact lens removal from the eye, participants will be advised to place clean the lenses with the HyCare MPDS (rub both sides of the lens with the MPDS using their forefinger and rinse with MPDS) and place the lenses directly into the appropriate lens case wells pre-filled with the HyCare MPDS. The lens case wells will then be capped, and lenses left overnight or for a minimum period of 4 hours (the manufacturer’s recommended minimum disinfection and cleaning time) to disinfect them. On removal of the contact lenses from the case after disinfection, participants will be required to rinse their lenses with the HyCare MPDS before placing them on their eyes. The participants will be asked to discard the remaining MPDS solution in the lens storage case wells, rinse the wells and lids thoroughly with fresh HyCare MPDS solution and to air dry the storage cases. Participants will be asked to return their used bottle of HyCare MPDS at the scheduled one-month (1 bottle) and three month (2 bottles) follow-up visits. These used MPDS bottles will be weighed to monitor participant compliance with use. The participants will be crossed over to use the control contact lens storage cases (without silver) for the following 3 months at the next visit without any washout.
Sponsors
CooperVision Inc
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 years or older at the time of screening. 2. Be a current frequent replacement soft contact lens wearer (hydrogel or silicone hydrogel) 3. Be willing to wear the contact lenses on a daily wear basis for a minimum of 4 days per week for the duration of the study and follow standard contact lens practice and precautions during lens wear 4. Be willing to use the study prescribed contact lens cleaning and disinfection solution and lens storage case for the duration of the study
Exclusion criteria
1. Daily disposable or extended wear soft contact lens wearer 2. Rigid gas permeable lens wearer (including orthokeratology). 3. Any ocular or systemic allergies or diseases that may interfere with contact lens wear. 4. Any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable. 5. Any ocular abnormalities such as entropion, ectropion, extrusions, chalazia, recurrent styes, history of recurrent corneal erosions. 6. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.). 7. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrolment. 8. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report. 9. Be currently pregnant or breastfeeding
Outcome results
None listed