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NCT03253393

Smart Touch Non-dispensing Handling Studies

Completed NA Results posted Last updated 3 December 2021
What this trial tests

NA trial testing Smart Touch Technology packaging in Optometry in 38 participants. Completed in 27 February 2019.

Timeline
4 June 2018
Primary endpoint
27 February 2019
27 February 2019

Quick facts

Lead sponsorThe University of New South Wales
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposebasic science
Enrollment38
Start date4 June 2018
Primary completion27 February 2019
Estimated completion27 February 2019
Sites1 location across Australia

Drugs / interventions tested

Conditions studied

Sponsor

The University of New South Wales

Who can join

18 and older, any sex, with Optometry. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Without Contamination of Contact Lenses Primary · After 45 minutes of lens wear

Number of Participants Without Contamination of Contact Lenses after 45 minutes of wear

GroupValue95% CI
Silicone Hydrogel (With EDTA) in Smart Touch16
Silicone Hydrogel (With EDTA) in Conventional Packaging9
Silicone Hydrogel (no EDTA) in Smart Touch4
Hydrogel (no EDTA) in Smart Touch14
Hydrogel (no EDTA) in Conventional Packaging7
Hydrogel (With EDTA) in Smart Touch16
Bacterial Counts of Worn Contact Lenses Secondary · After 45 minutes of lens wear

Bacterial counts of contact lenses after 45 minutes of wear (CFU count /lens)

GroupValue95% CI
Silicone Hydrogel (With EDTA) in Smart Touch00 – 43
Silicone Hydrogel (With EDTA) in Conventional Packaging10 – 25
Silicone Hydrogel (no EDTA) in Smart Touch40 – 10
Hydrogel (no EDTA) in Smart Touch00 – 17
Hydrogel (no EDTA) in Conventional Packaging10 – 16
Hydrogel (With EDTA) in Smart Touch00 – 9

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Factors Affecting Microbial Contamination on the Back Surface of Worn Soft Contact Lenses.
    Tan J, Siddireddy JS, Wong K, Shen Q, et al · · 2021 · cited 3× · PMID 33973914 · DOI 10.1097/opx.0000000000001693

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03253393.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing