Last updated on April 2019

Smart Touch Non-dispensing Handling Studies

Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT03253393

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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