Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001210662
Ethics application status
Approved
Date submitted
4/11/2014
Date registered
17/11/2014
Date last updated
11/11/2015
Type of registration
Prospectively registered

Titles & IDs
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.
Secondary ID [1] 285593 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Microbial contamination of used contact lens cases 293434 0
Condition category
Condition code
Infection 293706 293706 0 0
Studies of infection and infectious agents
Eye 293707 293707 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 290571 0
Prevention
Comparator / control treatment
The microbial contamination rates of used First Care contact lens storage cases will be compared with historical controls (c.f. Willcox et. al. Optom Vis Sci 2010;87:456-464). This data were collected from a series of dispensing clinical studies conducted at the Institute for Eye Research, Sydney. Approximately 40 participants were enrolled, and wore lenses on a daily wear basis for 3 months. The following lens/solution combinations were evaluated: OASYS/ClearCare; PureVision/Aquify; Biofinity/ClearCare; Biofinity/Aquify; Biofinity/Opti-Free Express; Biofinity/Opti-free RepleniSH.
Control group
Historical

Outcomes
Primary outcome [1] 293513 0
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.
Timepoint [1] 293513 0
1 month and 3 months after commencement of use of the study lens care product
Secondary outcome [1] 311217 0
Corneal and conjunctival staining using fluorescein dye and viewed with a slit lamp biomicroscope.
Timepoint [1] 311217 0
1 month and 3 months after commencement of use of the study lens care product
Secondary outcome [2] 311219 0
Subjective comfort questionnaire using visual analogue scales
Timepoint [2] 311219 0
1 month and 3 months after commencement of use of the study lens care product
Secondary outcome [3] 311459 0
User satisfaction using Likert scales
Timepoint [3] 311459 0
1 month and 3 months after commencement of use of the study lens care product

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
40 subjects will be enrolled. Assuming a case contamination rate of 80% with regular cases, a sample of 40 participants using the First Care contact lens case collected at two study visits is required to demonstrate a significant reduction of 50% (80% vs. 40%) in case contamination rates compared to historical controls. This sample was estimated at the 5% level of significance and with 90% power and assuming a 20% drop out rate.
The number of colony forming units (CFU) for different microbial types, and the percentage of contact lens storage cases contaminated with various microbial species will be calculated, and compared with historical controls.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2015
Actual
23/01/2015
Date of last participant enrolment
Anticipated
30/04/2015
Actual
27/07/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 8862 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 290184 0
Commercial sector/Industry
Name [1] 290184 0
Ophtecs Corporation
Country [1] 290184 0
Japan
Primary sponsor type
University
Name
University of New South Wales
Address
Sydney, NSW 2052
Country
Australia
Secondary sponsor category [1] 288896 0
Commercial sector/Industry
Name [1] 288896 0
Ophtecs Corporation
Address [1] 288896 0
5-2-4 Minatojima minamimachi,
Chuo-ku, Kobe
Country [1] 288896 0
Japan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291894 0
The Human Research Ethics Committee, University of New South Wales
Ethics committee address [1] 291894 0
Level 3, Rupert Myers Building, South Wing
Gate 14, Barker St.
Sydney NSW 2052
Ethics committee country [1] 291894 0
Australia
Date submitted for ethics approval [1] 291894 0
07/10/2014
Approval date [1] 291894 0
08/12/2014
Ethics approval number [1] 291894 0
HC14270

Summary
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.
Trial website
Trial related presentations / publications
Closed but data analysis is continuing
Public notes

Contacts
Principal investigator
Name 52490 0
Dr Jacqueline Tan-Showyin
Address 52490 0
School of Optometry and Vision Science, University of New South Wales
Level 3, Rupert Myers Building, North Wing
Gate 14, Barker St
Sydney NSW 2052
Country 52490 0
Australia
Phone 52490 0
+612 9385 6551
Fax 52490 0
Email 52490 0
[email protected]
Contact person for public queries
Name 52491 0
Dr Jacqueline Tan-Showyin
Address 52491 0
School of Optometry and Vision Science, University of New South Wales
Level 3, Rupert Myers Building, North Wing
Gate 14, Barker St
Sydney NSW 2052
Country 52491 0
Australia
Phone 52491 0
+612 9385 6551
Fax 52491 0
Email 52491 0
[email protected]
Contact person for scientific queries
Name 52492 0
Prof Mark Willcox
Address 52492 0
School of Optometry and Vision Science, University of New South Wales
Level 3, Rupert Myers Building, North Wing
Gate 14, Barker St
Sydney NSW 2052
Country 52492 0
Australia
Phone 52492 0
+612 9385 4164
Fax 52492 0
Email 52492 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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