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N/A Completed N=258 Randomized Single-blind Treatment

Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

Source: ClinicalTrials.gov NCT00909792 ↗
Enrolled (actual)
258
Serious AEs
0.0%
Results posted
Oct 2010
Primary outcomePrimary: Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity — -0.01; 0.01 logMAR

Summary

The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.

Outcome Measures

OutcomeResultp-value
PRIMARY
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
-0.01; 0.01

Eligibility Criteria

Inclusion Criteria

  • Be at least 35 years of age
  • Best-corrected distance visual acuity of at least 20/40 in each eye.
  • Spectacle add between +0.75D and +1.50D (inclusive).
  • Able to be fit in available study sphere powers (-1.00 to -5.00D)
  • Currently wearing soft contact lenses at least 5 days a week.
  • Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria

  • Eye injury or surgery within twelve weeks immediately prior to enrollment.
  • Currently enrolled in an ophthalmic clinical trial.
  • Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
  • Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
  • Astigmatism ≥ 1.00D.
  • Currently wearing either of the study products.
  • Other protocol inclusion/exclusion criteria may apply.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00909792). 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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