OptometryNCT03253393

Smart Touch Non-dispensing Handling Studies

A study testing Smart Touch Technology packaging, Conventional lens packaging and EDTA in people with Optometry, run by The University of New South Wales at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Optometry
What is being tested?: Smart Touch Technology packaging, Conventional lens packaging and EDTA
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteAustralia
Study dates: 4 Jun 2018to 27 Feb 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Australia1 site

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

Other trials in Australia

About this study

Official title: 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.

Read the 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
Being tested: Smart Touch Technology packaging, Conventional lens packaging, EDTA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03253393
Study group	Role	What they receive
Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging	Experimental	Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging Receives: 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 Receives: 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 Receives: Device: EDTA

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Without Contamination of Contact Lenses
Number of Participants Without Contamination of Contact Lenses after 45 minutes of wear
Measured: After 45 minutes of lens wear

Secondary outcomes (1)

Bacterial Counts of Worn Contact Lenses
Bacterial counts of contact lenses after 45 minutes of wear (CFU count /lens)
Measured: After 45 minutes of lens wear

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jun 201827 Feb 2019

First posted17 Aug 2017
Study start4 Jun 2018
Primary completion27 Feb 2019
Study completion27 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OptometryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: Contralateral study
Masking: Single blind
Who is masked: Investigator
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03253393
Sponsor's protocol ID: SOVS2017-050
Status last verified: Nov 2021
First submitted: 15 Aug 2017
Last updated: 3 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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.
PubMed 33973914

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Not yet recruitingObservational study
Clinical Validation Study Protocol for SmartEyes Smart Optometry Measurement Device (Medical Device Clinical Validation Study)
Refractive Errors
Enrolling by invitation
Smart Soft Contact Lenses for Monitoring Glaucoma
Glaucoma
Recruiting
The Effect of Rinsing on Ocular Inflammation and Symptoms in Patients With Dry Eye Disease
Dry Eye Syndromes, Dry Eye
Recruiting
Clinical Performance of Verofilcon A Toric Contact Lenses
Contact Lenses, Presbyopia

All Optometry trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Microbial Contamination Rates on the Back Surface of Soft Contact Lenses in Two Short-term, Randomized, Contralateral Non-dispensing Studies
ClinicalTrials.gov ID: NCT03253393
Acronym / sponsor ID: SOVS2017-050
Conditions: Optometry
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: The University of New South WalesUniversity, hospital or other
Collaborators: Menicon Co., Ltd.
Study start: 4 Jun 2018 (actual)
Primary completion: 27 Feb 2019 (actual)
Study completion: 27 Feb 2019 (actual)
First posted: 17 Aug 2017 (actual)
Results: Posted 2 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 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 design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 3
Model description: Contralateral study

Arm	Type	Receives
Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging	Experimental	Device: Smart Touch Technology packaging, Device: Conventional lens packagingSilicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging
Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging	Experimental	Device: Smart Touch Technology packaging, Device: Conventional lens packagingHydrogel (no EDTA) in Smart Touch vs. in conventional packaging
Silicone hydrogel (no EDTA) vs. hydrogel (with EDTA) in Smart Touch	Experimental	Device: EDTASilicone hydrogel (no EDTA) vs. hydrogel (with EDTA) in Smart Touch

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Smart Touch Technology packaginghioxifilcon A contact lens in Smart Touch Technology (hydrogel, no EDTA) midafilcon A contact lens in Smart Touch Technology (silicone hydrogel, with EDTA)	Device	Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging, Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging
Conventional lens packaginghioxifilcon A contact lens in conventional lens packaging (hydrogel, no EDTA) midafilcon A contact lens in conventional lens packaging (silicone hydrogel, with EDTA)	Device	Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging, Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging
EDTAhioxifilcon A contact lens in Smart Touch Technology (hydrogel, with EDTA) midafilcon A contact lens in Smart Touch Technology (silicone hydrogel, no EDTA)	Device	Silicone hydrogel (no EDTA) vs. hydrogel (with EDTA) in Smart Touch

Primary outcome

Number of Participants Without Contamination of Contact Lenses
Time frame: After 45 minutes of lens wear
Number of Participants Without Contamination of Contact Lenses after 45 minutes of wear

1 secondary outcome

Bacterial Counts of Worn Contact Lenses
Time frame: After 45 minutes of lens wear

Results and safety

Results posted to the registry on 2 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SiH (With EDTA) , Then H (no EDTA), Then SiH (Without EDTA) and H (With EDTA) in Smart Touch	12	12
H (no EDTA), Then SiH (With EDTA), Then SiH (Without EDTA) vs H (With EDTA) in Smart Touch	13	13
SiH (Without EDTA) in Smart Touch vs H (With EDTA) in Smart Touch	0	0

Primary outcome: Number of Participants Without Contamination of Contact Lenses

Time frame: After 45 minutes of lens wear. Count of participants. Unit: Participants

Measure	Silicone Hydrogel (With EDTA) in Smart Touch n = 25	Silicone Hydrogel (With EDTA) in Conventional Packaging n = 25	Silicone Hydrogel (no EDTA) in Smart Touch n = 25	Hydrogel (no EDTA) in Smart Touch n = 25	Hydrogel (no EDTA) in Conventional Packaging n = 25	Hydrogel (With EDTA) in Smart Touch n = 25
Value	16	9	4	14	7	16

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Participants were monitored for adverse events occurring during lens wear i.e. 45 minutes for each visit, up to 3 visits.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Silicone Hydrogel (With EDTA) in Smart Touch	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Silicone Hydrogel (With EDTA) in Conventional Packaging	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Silicone Hydrogel (no EDTA) in Smart Touch	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Hydrogel (no EDTA) in Smart Touch	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Hydrogel (no EDTA) in Conventional Packaging	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Hydrogel (With EDTA) in Smart Touch	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33973914Tan 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.
Individual participant dataSharing planned: No

Related trials for Optometry

RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Not yet recruitingObservational study
Clinical Validation Study Protocol for SmartEyes Smart Optometry Measurement Device (Medical Device Clinical Validation Study)
Refractive Errors
Enrolling by invitation
Smart Soft Contact Lenses for Monitoring Glaucoma
Glaucoma
Recruiting
The Effect of Rinsing on Ocular Inflammation and Symptoms in Patients With Dry Eye Disease
Dry Eye Syndromes, Dry Eye
Recruiting
Clinical Performance of Verofilcon A Toric Contact Lenses
Contact Lenses, Presbyopia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Smart Touch Technology packaging, Conventional lens packaging and EDTA in people with Optometry, run by The University of New South Wales at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Without Contamination of Contact Lenses (time frame: After 45 minutes of lens wear). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03253393, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.