None listed
Conditions
Brief summary
First Care is the only product on the market of its kind that uses Povidone-iodine as a disinfectant. Povidone-iodine is the most commonly used medical disinfectant, and First Care has been shown to be a safe and efficient care product for all types of frequent replacement contact lenses. First Care is currently approved for sale in Japan. We hope to learn how effective the First Care system is, for reducing microbial contamination (e.g. bacteria and fungi) of used contact lens storage cases over a 3 month period, and to compare the results to other commercially available frequent replacement contact lens cleaning and disinfecting solution storage cases (using historical controls). We hypothesize that the microbial contamination rates of used First Care cleaning and disinfecting system lens storage cases will be lower compared to used lens storage cases of other commercially available frequent replacement contact lens cleaning and disinfecting solutions.
Interventions
The unique povidone-iodine based contact lens cleaning and disinfecting system First Care, will be dispensed to 40 regular, daily wear, frequent replacement soft contact lens wearers, for use with their own contact lenses over a period of 3 months. The efficacy of this system, against ocular pathogens in vivo, will be determined as measured via used contact lens storage case microbial contamination rates.
The product contains: 2-layered tablets with the disinfectant (Povidone-iodine) in the oute
The unique povidone-iodine based contact lens cleaning and disinfecting system First Care, will be dispensed to 40 regular, daily wear, frequent replacement soft contact lens wearers, for use with their own contact lenses over a period of 3 months. The efficacy of this system, against ocular pathogens in vivo, will be determined as measured via used contact lens storage case microbial contamination rates. The product contains: 2-layered tablets with the disinfectant (Povidone-iodine) in the outer layer and both the neutralizer and protein remover in the inner layer; dissolving and rinsing solution and; lens case. After daily removal of contact lenses from the eyes, contact lenses are placed in the appropriate compartment (right eye or left eye) of the lens case and the basket is closed. The lens case is filled with First Care dissolving and rinsing solution, and the 2-layered tablet is added to the lens case. The lens case cap is secured on and contact lenses are to be kept in the case for at least 4 hours for the disinfecting, neutralizing and cleaning process to be completed. Contact lenses are removed from the basket and rinsed with fresh First Care dissolving and rinsing solution before inserting the lenses on eye. Participants will be asked to use the First Care system each day after removal of their contact lenses, prior to sleep. Participants will be provided with sufficient study product to last up until their next visit. Compliance with use of the study product will be monitored at the follow-up visits, when unused study product will be returned.
Sponsors
University of New South Wales
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Existing frequent replacement contact lens wearer (hydrogel or silicone hydrogel); Willing to wear their contact lenses on a daily wear basis (no overnight wear) for a minimum of 4 days per week (on average) for the duration of the study; Willing to use the study prescribed contact lens cleaning 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 iodine 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; Pregnancy if female.
Outcome results
None listed