Smart Touch Non-dispensing Handling Studies

NCT03253393 | Completed Results FDA Device

• 1 other identifier: SOVS2017-050
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Optometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Bacterial Counts of Worn Contact Lenses

  After 45 minutes of lens wear

Study Arms (3)

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

EXPERIMENTAL

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

Device: Smart Touch Technology packaging; Device: Conventional lens packaging

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

EXPERIMENTAL

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

Device: Smart Touch Technology packaging; Device: Conventional lens packaging

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

EXPERIMENTAL

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

Device: EDTA

Interventions

Smart Touch Technology packaging DEVICE

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

Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging; Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging

Conventional lens packaging DEVICE

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

Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging; Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging

EDTA DEVICE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of New South Wales: lead
• Menicon Co., Ltd.: collaborator

Study Sites (1)

School of Optometry and Vision Science

Sydney, New South Wales, 2052, Australia

Location

Related Publications (1)

• 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.

  PMID: 33973914 DERIVED

Results Point of Contact

• Title: Dr Jacqueline Tan
• Organization: University of New South Wales

jacqueline.tan@unsw.edu.au

+612 9385 6551

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Model Details: Contralateral study

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 17, 2017
• Study Start: June 4, 2018
• Primary Completion: February 27, 2019
• Study Completion: February 27, 2019
• Last Updated: December 3, 2021
• Results First Posted: November 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)