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

Phase 2

Completed

• Conditions: Microbial contamination of used contact lens cases; Infection - Studies of infection and infectious agents; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12614001210662
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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];Subjective comfort questionnaire using visual analogue scales[1 month and 3 months after commencement of use of the study lens care product];User satisfaction using Likert scales[1 month and 3 months after commencement of use of the study lens care product]