Smart Touch Non-dispensing Handling Studies

Microbial Contamination Rates on the Back Surface of Soft Contact Lenses in Two Short-term, Randomized, Contralateral Non-dispensing Studies

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.

Study Overview

• Status: Completed
• Conditions: Optometry
• Intervention / Treatment: Device: Smart Touch Technology packaging; Device: Conventional lens packaging; Device: EDTA

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2052
      • School of Optometry and Vision Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging	Device: 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); Device: 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)
Experimental: Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging	Device: 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); Device: 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)
Experimental: Silicone hydrogel (no EDTA) vs. hydrogel (with EDTA) in Smart Touch	Device: EDTA; hioxifilcon A contact lens in Smart Touch Technology (hydrogel, with EDTA) midafilcon A contact lens in Smart Touch Technology (silicone hydrogel, no EDTA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Without Contamination of Contact Lenses	Number of Participants Without Contamination of Contact Lenses after 45 minutes of wear	After 45 minutes of lens wear

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial Counts of Worn Contact Lenses	Bacterial counts of contact lenses after 45 minutes of wear (CFU count /lens)	After 45 minutes of lens wear

Collaborators and Investigators

• Sponsor: The University of New South Wales
• Collaborators: Menicon Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2018
• Primary Completion (Actual): February 27, 2019
• Study Completion (Actual): February 27, 2019

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): December 3, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SOVS2017-050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes