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Smart Touch Non-dispensing Handling Studies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03253393
Recruitment Status : Completed
First Posted : August 17, 2017
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
Menicon Co., Ltd.
Information provided by (Responsible Party):
Jacqueline Tan-Showyin, The University of New South Wales

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.

Condition or disease Intervention/treatment Phase
Optometry Device: Smart Touch Technology Device: Conventional lens packaging Not Applicable

Detailed Description:

This will be a prospective, single centre, randomized, contralateral, investigator-masked non-dispensing study. This study requires two visits of approx. 1 hour duration each.

At the first visit, if possible, the order in which the hydrogel and silicone hydrogel 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 or silicone hydrogel).

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 two study visits.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Contralateral study
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Microbial Contamination Rates on the Back Surface of Soft Contact Lenses in Two Short-term, Randomized, Contralateral Non-dispensing Studies
Actual Study Start Date : June 4, 2018
Actual Primary Completion Date : February 27, 2019
Actual Study Completion Date : February 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Smart Touch Technology Contact Lens Device: Smart Touch Technology
hioxifilcon A contact lens in Smart Touch Technology Flat Pack (hydrogel) asmofilcon A contact lens in Smart Touch Technology Flat Pack (silicone hydrogel)
Other Name: Miru 1day Menicon Flat Pack (hydrogel)

Active Comparator: Contact Lens in Conventional Packaging Device: Conventional lens packaging
hioxifilcon A contact lens in conventional lens packaging (hydrogel) asmofilcon A contact lens in conventional lens packaging (silicone hydrogel)
Other Name: PremiO (silicone hydrogel)




Primary Outcome Measures :
  1. Microbial contamination of lenses [ Time Frame: After 45 minutes of lens wear ]
    Microbial contamination rate of the back surface of worn soft contact lenses


Secondary Outcome Measures :
  1. Microbial contamination rate of participants' hands [ Time Frame: Hand swabs compared to contact lens contamination after 45 minutes of lens wear ]
    Microbial contamination rate of participants' hand swabs compared to the worn contact lenses



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253393


Locations
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Australia, New South Wales
School of Optometry and Vision Science
Sydney, New South Wales, Australia, 2052
Sponsors and Collaborators
The University of New South Wales
Menicon Co., Ltd.
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Responsible Party: Jacqueline Tan-Showyin, Senior Research Fellow, The University of New South Wales
ClinicalTrials.gov Identifier: NCT03253393    
Other Study ID Numbers: SOVS2017-050
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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