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N/A Completed N=47 Randomized

DAILIES TOTAL1® Lens Centration in a Japanese Population

Source: ClinicalTrials.gov NCT02252133 ↗
Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: Success Rate of Lens Centration After 7 ± 2 Days of Wear — 100.0; 86.7 percentage of subjects

Summary

The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2 days of wearing of each product.

Outcome Measures

OutcomeResultp-value
PRIMARY
Success Rate of Lens Centration After 7 ± 2 Days of Wear
100.0; 86.7 —

Eligibility Criteria

Inclusion Criteria

  • Sign Informed Consent document.
  • Habitually wear soft contact lenses on a daily disposable or weekly/monthly replacement basis.
  • Symptoms of contact lens discomfort as defined by protocol.
  • Require contact lenses within the power range of -0.50 diopter (D) to -10.00 D.
  • Cylinder, if present, less or equal to 0.75D in either eyes at Visit 1.
  • Vision correctable to 20/25 or 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
  • Acceptable contact lens fit with both study contact lenses.
  • Willing to wear lenses every day for at least for a minimum of five days per week six hours per day, every day if possible and attend all study visits.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

  • Currently wearing DT1 or 1DAVTE.
  • Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
  • Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator.
  • Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
  • Any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit.
  • History of herpetic keratitis, ocular surgery or irregular cornea.
  • Prior refractive surgery (e.g. LASIK, PRK, etc).
  • Monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
  • Judged ineligible as a patient in this clinical study by the investigator.
  • Other protocol-defined exclusion criteria may apply.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02252133). 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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