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N/A Completed N=99 Randomized Single-blind Treatment

Clinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population

Source: ClinicalTrials.gov NCT02710292 ↗
Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear — 89.5; 47.4 percentage of subjects

Summary

The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE) for Investigator-rated successful lens centration in Japanese population.

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear
89.5; 47.4 —

Eligibility Criteria

Inclusion Criteria

  • Must sign an informed consent form;
  • Habitual current daily disposable soft contact lenses wearer;
  • Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
  • Lenses within the power range specified in the protocol;
  • Vision correctable to 20/25 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit1;
  • Acceptable lens fit with both study contact lenses;
  • Willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

  • Currently wearing DT1 or TE sphere lenses;
  • Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
  • Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator;
  • Eye injury or surgery within 12 weeks immediately prior to enrollment;
  • History of herpetic keratitis, ocular surgery or irregular cornea;
  • Prior refractive surgery;
  • Monocular (only 1 eye with functional vision) or fit with only 1 lens;
  • Participation in any clinical trial within 30 days of the enrollment visit;
  • Other protocol-specified exclusion criteria may apply.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02710292). 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.

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