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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03253393




Registration number
NCT03253393
Ethics application status
Date submitted
15/08/2017
Date registered
17/08/2017
Date last updated
3/12/2021

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
SOVS2017-050
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

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

Experimental: Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging - Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging

Experimental: Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging - Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging

Experimental: Silicone hydrogel (no EDTA) vs. hydrogel (with EDTA) in Smart Touch - Silicone hydrogel (no EDTA) vs. hydrogel (with EDTA) in Smart Touch


Treatment: Devices: Smart Touch Technology packaging
hioxifilcon A contact lens in Smart Touch Technology (hydrogel, no EDTA) midafilcon A contact lens in Smart Touch Technology (silicone hydrogel, with EDTA)

Treatment: Devices: Conventional lens packaging
hioxifilcon A contact lens in conventional lens packaging (hydrogel, no EDTA) midafilcon A contact lens in conventional lens packaging (silicone hydrogel, with EDTA)

Treatment: Devices: EDTA
hioxifilcon A contact lens in Smart Touch Technology (hydrogel, with EDTA) midafilcon A contact lens in Smart Touch Technology (silicone hydrogel, no EDTA)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Without Contamination of Contact Lenses
Timepoint [1] 0 0
After 45 minutes of lens wear
Secondary outcome [1] 0 0
Bacterial Counts of Worn Contact Lenses
Timepoint [1] 0 0
After 45 minutes of lens wear

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/02/2019
Sample size
Target
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
NSW
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
Other
Name
The University of New South Wales
Address
Country
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

Summary
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
https://clinicaltrials.gov/ct2/show/NCT03253393
Trial related presentations / publications
Public notes

Contacts
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