N/A
Completed N=246
ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®
Source: ClinicalTrials.gov NCT02750813 ↗Enrolled (actual)
246
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14 — 100.0; 99.4 percentage of lenses
Summary
The purpose of this study is to compare the lens fit characteristics, specifically lens centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14 |
100.0; 99.4 | — |
| SECONDARY Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14 |
0.0468; 0.0675 | — |
Eligibility Criteria
Inclusion Criteria
- Must sign informed consent form;
- Adapted, current daily disposable soft contact lens wearer who typically wears lenses every day, or at least 5 days per week, 6 hours per day;
- Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Pre-screening questionnaire;
- Prescription within -1.00 Diopter (D) to -6.00D to be fitted with study contact lenses;
- Cylinder equal or lower than -0.75D in both eyes;
- Vision correctable to 20/25 or 0.1 logMAR (Logarithmic minimum angle of resolution) or better in each eye at distance with both study lenses at Visit 1;
- Can be successfully fitted with both study lenses at Visit 1;
- Willing to wear lenses every day or at least 5 days per week, 6 hours per day and attend all study visits;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- Fitted with monovision;
- Prior refractive surgery;
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Pregnant or lactating;
- Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
- Participation in any clinical study within 30 days of Visit 1;
- Current DT1 or AO1D lens wearer;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02750813). 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.