Status:
COMPLETED
Smart Touch Non-dispensing Handling Studies
Lead Sponsor:
The University of New South Wales
Collaborating Sponsors:
Menicon Co., Ltd.
Conditions:
Optometry
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
This will be a prospective, single centre, randomized, contralateral, investigator-masked non-dispensing study. This study requires three visits of approx. 1 hour duration each. At the first visit, t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
June 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2019
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03253393
Start Date
June 4 2018
End Date
February 27 2019
Last Update
December 3 2021
Active Locations (1)
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1
School of Optometry and Vision Science
Sydney, New South Wales, Australia, 2052