Mode
Text Size
Log in / Sign up
N/A Completed N=246 Randomized Double-blind Treatment

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

Back to search