Clinical trial NCT03253393: Smart Touch Non-dispensing Handling Studies
Official title: Microbial Contamination Rates on the Back Surface of Soft Contact Lenses in Two Short-term, Randomized, Contralateral Non-dispensing Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optometry
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: Menicon Co., Ltd.
First posted: 2017-08-17
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Contralateral study
Primary purpose: BASIC_SCIENCE

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.

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, the order in which the hydrogel (no EDTA) and silicone hydrogel (with EDTA) contact lenses are allocated to the study participants will be randomized. At the second visit, participants will be crossed over to the alternate lens type (hydrogel no EDTA or silicone hydrogel with EDTA).

At the third visit, participants will be randomly allocated to wear the hydrogel lens (with EDTA) in one eye and the silicone hydrogel lens (no EDTA) in the other eye, both removed from Smart Touch Technology packaging.

At each visit, participants will be instructed to:

* Wash their hands prior to handling the contact lenses;
* Swab their thumb and two index fingers of the hand routinely used to conduct contact lens insertion using a sterile cotton swab moistened with sterile preservative free saline for the evaluation of skin microbiota;
* Follow the manufacturer's guidelines for lens insertion;
* Open the blister pack and insert the contact lens randomly assigned for the right eye;
* Open the blister pack and insert the contact lens assigned for the left eye;
* Contact lenses will be removed aseptically by a masked investigator after 45 minutes of lens wear.

Lenses and finger swabs will be analysed for microbial contamination using established routine microbiology protocols. The number and species of organisms will be determined.

A minimum washout period of 48 hours will occur between the study visits.

Eligibility criteria: 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

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)

Primary outcomes:
measure: Number of Participants Without Contamination of Contact Lenses
timeFrame: After 45 minutes of lens wear
Secondary outcomes:
measure: Bacterial Counts of Worn Contact Lenses
timeFrame: After 45 minutes of lens wear
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: School of Optometry and Vision Science
state: New South Wales
Study officials:
References:
citation: Tan J, Siddireddy JS, Wong K, Shen Q, Vijay AK, Stapleton F. Factors Affecting Microbial Contamination on the Back Surface of Worn Soft Contact Lenses. Optom Vis Sci. 2021 May 1;98(5):512-517. doi: 10.1097/OPX.0000000000001693.