CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 38 enrolled
Drug / intervention
Smart Touch Technology packaging +2 moredevice
Likely dose
Not stated in record
Key inclusion· 4
  • Experienced soft contact lens wearer
  • At least 18 years old
  • Able to read and comprehend English and provide informed consent
  • Willing to refrain from wearing contact lenses for 24 hours prior to study visit
Key exclusion· 7
  • Active corneal infection, ocular disease, or systemic disease affecting contact lens wear
  • Use of systemic or topical medications that may alter ocular findings or affect ocular health/physiology
  • Eye surgery within 12 weeks prior to enrollment
  • Contraindications to contact lens wear

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03253393
NCT03253393N/ACompleted

Microbial Contamination Rates on the Back Surface of Soft Contact Lenses in Two Short-term, Randomized, Contralateral Non-dispensing Studies

The University of New South Wales·interventional·Posted Aug 17, 2017·Updated Dec 3, 2021

In Brief

A clinical study evaluating Smart Touch Technology packaging, Conventional lens packaging, and 1 other intervention for Optometry. Completed, enrolled 38 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOptometry
CountriesAustralia
CollaboratorsMenicon Co., Ltd.

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 17, 2017
Enrollment StartJun 4, 2018
Primary CompletionFeb 27, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.9 years ago

Interventions

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)