N/A
Completed N=25
Smart Touch Non-dispensing Handling Studies
Optometry
Source: ClinicalTrials.gov NCT03253393 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Number of Participants Without Contamination of Contact Lenses — 16; 9; 4; 14 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Without Contamination of Contact Lenses |
16; 9; 4; 14; 7; 16 | — |
| SECONDARY Bacterial Counts of Worn Contact Lenses |
0; 1; 4; 0; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT03253393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.