A 3 month dispensing study of First Care cleaning and disinfecting solution in daily wear, frequent replacement soft contact lens wearers

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001210662
• Date of registration: 17/11/2014
• Prospective Registration: Yes
• Primary sponsor: University of New South Wales
• Public title: A 3 month dispensing study of First Care cleaning and disinfecting solution in daily wear, frequent replacement soft contact lens wearers
• Scientific title: Evaluation of the microbial contamination rate of used First Care contact lens cases collected from regular, daily wear, frequent replacement soft contact lens wearers at the 1 month and 3 month follow-up visits compared to historical controls.
• Date of first enrolment: 23/01/2015
• Target sample size: 40
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614001210662.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
• Phase: Phase 2

Countries of recruitment

Australia

Contacts

• Name: Dr Jacqueline Tan-Showyin

• Name: Prof Mark Willcox

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Microbial contamination of used contact lens cases;
Microbial contamination of used contact lens cases

Eye - Diseases / disorders of the eye

Infection - Studies of infection and infectious agents

Intervention(s)

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.

Primary Outcome(s)

Microbial contamination rates of used First Care contact lens storage cases. Lens cases will be sent to the Microbiology Laboratory within one hour of collection, where they will be swabbed using an alginate swab soaked in phosphate-buffered saline containing 1% (wt/vol) sodium hexametaphosphate to dissolve the alginate. After mixing for 30 s, the solution will be cultured by plating aliquots onto three "chocolate" agar plates and one Sabouraud dextrose agar plate. One each of the chocolate agar plates will be incubated at 37degC in 5% CO2 (2 days), one in aerobic conditions (2 days) and one under anaerobic conditions (4 days). Sabouraud dextrose agar will be incubated at 25degC for 7 days to culture for yeast and molds. The number of colony forming units will be calculated for each microbial type. [1 month and 3 months after commencement of use of the study lens care product]

Secondary Outcome(s)

User satisfaction using Likert scales[1 month and 3 months after commencement of use of the study lens care product]

Subjective comfort questionnaire using visual analogue scales[1 month and 3 months after commencement of use of the study lens care product]

Corneal and conjunctival staining using fluorescein dye and viewed with a slit lamp biomicroscope.[1 month and 3 months after commencement of use of the study lens care product]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Ophtecs Corporation

Secondary Sponsor(s)

Ophtecs Corporation

Ethics review

Status: Approved
Approval date:
Contact:

The Human Research Ethics Committee, University of New South Wales