Smart Touch Non-dispensing Handling Studies

NCT ID: NCT03253393

Last Updated: 2021-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-04
• Study Completion Date: 2019-02-27

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.

Conditions

Optometry

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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

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

Group Type: EXPERIMENTAL

Smart Touch Technology packaging

Intervention Type: DEVICE

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

Conventional lens packaging

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Smart Touch Technology packaging

Intervention Type: DEVICE

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

Conventional lens packaging

Intervention Type: DEVICE

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

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

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

Group Type: EXPERIMENTAL

EDTA

Intervention Type: DEVICE

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

Interventions

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)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Menicon Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

The University of New South Wales

OTHER

Sponsor Role: lead

Responsible Party

Jacqueline Tan-Showyin

Senior Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Optometry and Vision Science

Sydney, New South Wales, Australia

Countries

Australia

References

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.

Reference Type: DERIVED

PMID: 33973914 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SOVS2017-050

Identifier Type: -

Identifier Source: org_study_id