N/A
N=15
DAILIES TOTAL1® Lubricity Post Wear
Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT02072980 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn — 0.0394; 0.0396 unitless
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Delefilcon A contact lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn |
0.0394; 0.0396 | — |
| SECONDARY Average Coefficient of Friction at 15 Minutes |
0.0392 | — |
Summary
The primary objective of the study is to demonstrate that the lubricity of DAILIES TOTAL1® (DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses.
Eligibility Criteria
Inclusion Criteria
- Willing and able to sign Informed Consent document.
- Adapted, current soft contact lens wearer.
- Requires contact lens powers within the specified range of -0.50 diopters (D) to -10.00D.
- Cylinder between 0.00D and -1.00D (inclusive) in both eyes at Visit 1 manifest refraction.
- Vision correctable to 20/25 or better in each eye at distance with study lenses.
- Willing to wear study lenses at least 16 waking hours in one day and attend all study visits.
- Able to be successfully fitted with study lenses.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Any ocular infection, inflammation, abnormality or active disease that would contraindicate contact lens wear, as determined by the Investigator.
- Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
- Use of artificial tears and rewetting drops during the study.
- Monocular (only one eye with functional vision) or fit with only one lens.
- Any abnormal ocular condition observed during the Visit 1 slit lamp examination.
- History of herpetic keratitis, ocular surgery, or irregular cornea.
- Pregnant.
- Participation in any clinical study within 30 days of Visit 1.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02072980). 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.