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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Smart Touch Non-dispensing Handling Studies
Scientific title
Microbial Contamination Rates on the Back Surface of Soft Contact Lenses in Two Short-term, Randomized, Contralateral Non-dispensing Studies
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Optometry 0 0
Condition category
Condition code

Study type
Description of intervention(s) / exposure
Treatment: Devices - Smart Touch Technology
Treatment: Devices - Conventional lens packaging

Experimental: Smart Touch Technology Contact Lens -

Active Comparator: Contact Lens in Conventional Packaging -

Treatment: Devices: Smart Touch Technology
hioxifilcon A contact lens in Smart Touch Technology Flat Pack (hydrogel) asmofilcon A contact lens in Smart Touch Technology Flat Pack (silicone hydrogel)

Treatment: Devices: Conventional lens packaging
hioxifilcon A contact lens in conventional lens packaging (hydrogel) asmofilcon A contact lens in conventional lens packaging (silicone hydrogel)

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Microbial contamination of lenses - Microbial contamination rate of the back surface of worn soft contact lenses
Timepoint [1] 0 0
After 45 minutes of lens wear
Secondary outcome [1] 0 0
Microbial contamination rate of participants' hands - Microbial contamination rate of participants' hand swabs compared to the worn contact lenses
Timepoint [1] 0 0
Hand swabs compared to contact lens contamination after 45 minutes of lens wear

Key inclusion criteria
- Able to read and comprehend English and give informed consent as demonstrated by
signing a Participant Information Statement and Consent Form;

- Be at least 18 years old;

- Experienced soft contact lens wearer;

- Willing to refrain from wearing contact lenses for 24 hours prior to the scheduled
study visit
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Under 18 years old;

- Have any active corneal infection, ocular disease or systemic disease that would
affect wearing of contact lenses;

- Use or have a need for any systemic or topical medications which may alter normal
ocular findings/are known to affect a participant's ocular health/physiology either in
an adverse manner or risk providing a false positive;

- Have had eye surgery within 12 weeks immediately prior to enrolment for this trial;

- Have contraindications to contact lens wear;

- Have a greater than 2 line reduction in habitual visual acuity while wearing the study
contact lenses;

- Be currently enrolled in another clinical trial;

- Be pregnant (verbal self-report)

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?

The people analysing the results/data
Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
School of Optometry and Vision Science - Sydney
Recruitment postcode(s) [1] 0 0
2052 - Sydney

Funding & Sponsors
Primary sponsor type
The University of New South Wales
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Menicon Co., Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Brief summary
This study is a randomized, contralateral, investigator-masked non-dispensing study, to
investigate the microbial contamination rates on the back surface of two types of soft
contact lenses (hydrogel and silicone hydrogel) extracted from Smart Touch Technology blister
packs versus conventional lens packaging after short-term placement on the eye, and to
compare the microbial contamination rates of the worn contact lenses to those on the
participants' hands/fingers used to conduct lens insertion.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications