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N/A Completed N=24 Randomized Single-blind Treatment

DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance

Source: ClinicalTrials.gov NCT02235831 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance — 0.09; 0.18; 0.24; 0.36 diopter*logMar

Summary

The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort Plus® (DACP) MF contact lens using new objective measurements.

Outcome Measures

OutcomeResultp-value
PRIMARY
Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance
0.09; 0.18; 0.24; 0.36 —

Eligibility Criteria

Inclusion Criteria

  • History of soft contact lens wear (hydrogel or silicone hydrogel) in both eyes during the past 3 months and able to wear lenses at least 8 hours a day, 5 days a week
  • Spectacle add between +1.50 and +2.50 diopters (D) (inclusive)
  • Requiring lenses within the power range of both study contact lenses to be fitted
  • Cylinder, if present, less or equal to 0.50D in both eyes at Visit 1
  • Vision correctable to 20/30 (0.2 logMAR) or better in each eye at distance
  • Acceptable fit with both study contact lenses
  • Willing to wear lenses every day or at least for a minimum of 5 days per week 6 hours per day, every day if possible
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria

  • Current multifocal contact lens wearer
  • Current monovision wearer or failed attempt with monovision
  • 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 12 weeks immediately prior to enrollment in this trial
  • Any moderate or severe ocular condition observed during the slitlamp examination at the enrollment visit
  • History of herpetic keratitis, ocular surgery or irregular cornea
  • Prior refractive surgery (e.g. LASIK, PRK, etc)
  • Monocular (only 1 eye with functional vision) or fit with only 1 lens
  • Habitually uncorrected anisometropia >2.00D
  • Clinically significant anisocoria
  • Participation in any clinical trial within 30 days of the enrollment visit
  • Other protocol-defined exclusion criteria may apply
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02235831). 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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