Smart Touch Non-dispensing Handling Studies
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|ClinicalTrials.gov Identifier: NCT03253393|
Recruitment Status : Completed
First Posted : August 17, 2017
Last Update Posted : April 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Optometry||Device: Smart Touch Technology Device: Conventional lens packaging||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Contralateral study|
|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|
|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)
- Microbial contamination of lenses [ Time Frame: After 45 minutes of lens wear ]Microbial contamination rate of the back surface of worn soft contact lenses
- 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
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
|Australia, New South Wales|
|School of Optometry and Vision Science|
|Sydney, New South Wales, Australia, 2052|