N/A
N=121
Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01561560 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: End-of-day Comfort — 8.3; 6.6 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Delefilcon A contact lenses (Device); Narafilcon A contact lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY End-of-day Comfort |
8.3; 6.6 | — |
Summary
The purpose of this crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses.
Eligibility Criteria
Inclusion Criteria
- Sign written Informed Consent Document.
- Currently wearing soft contact lenses in both eyes and identified as symptomatic based on questionnaire responses.
- Currently wearing either daily disposable contact lenses or weekly/monthly replacement contact lenses.
- Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters.
- Willing to wear study lenses for at least eight hours per day and at least five days per week.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Has not worn contact lenses before.
- Currently wearing DAILIES TOTAL1 or 1-DAY ACUVUE TRUEYE contact lenses.
- Any systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
- Ocular surgery/trauma within the last six months.
- Topical ocular or systemic use of antibiotics within seven days of enrollment.
- Pregnant or nursing women.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01561560). 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.