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Clinical Trials/NCT01254760
NCT01254760
Completed
Not Applicable

Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis

CIBA VISION0 sites79 target enrollmentDecember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Presbyopia
Sponsor
CIBA VISION
Enrollment
79
Primary Endpoint
End of Day Comfort
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

The purpose of this trial is to evaluate and compare the clinical performance of two multifocal contact lenses.

Registry
clinicaltrials.gov
Start Date
December 2010
End Date
January 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
CIBA VISION
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 41 to 68 (inclusive).
  • Spectacle add between +0.75 and +2.75D (inclusive).
  • Habitual spectacle prescription ≤ 1.00DC (cyl).
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

  • Eye injury or surgery within twelve weeks of enrollment.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in a clinical trial.
  • Prior refractive surgery.
  • Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

End of Day Comfort

Time Frame: 5 days of wear, lenses replaced daily

End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.

End of Day Dryness

Time Frame: 5 days of wear, lenses replaced daily

End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.

Handling at Removal

Time Frame: 5 days of wear, lenses replaced daily

Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.

Overall Vision

Time Frame: 5 days of wear, lenses replaced daily

Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.

Secondary Outcomes

  • Overall Fit(Day 5, lenses replaced daily)

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