Comparison of Two Multifocal Contact Lenses

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: Lotrafilcon B contact lens; Device: Comfilcon A contact lens

• Registration Number: NCT01250054
• Lead Sponsor: CIBA VISION

Brief Summary

The purpose of this study is to compare two multifocal contact lenses in presbyopic wearers.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Study First Submitted: 2010-11-29
• Study First Submitted QC: 2010-11-29
• Study First Posted: 2010-11-30
• Status Verified: 2011-07
• Results First Submitted: 2011-07-19
• Results First Submitted QC: 2011-07-19
• Results First Posted: 2011-08-12
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• At least 35 years of age.
• Sign written Informed Consent
• Spectacle add of +0.50 to +2.50D.
• Best corrected visual acuity of at least 20.30 in both eyes.
• Currently wearing soft contact lenses at least 5 days per week.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Eye injury or surgery within twelve weeks of enrollment.
• Currently enrolled in any clinical trial.
• Astigmatism > 1.00D.
• Strabismus/amblyopia.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lotrafilcon B / Comfilcon A	Lotrafilcon B contact lens	Lotrafilcon B multifocal contact lenses worn first, with comfilcon A multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
Comfilcon A /Lotrafilcon B	Comfilcon A contact lens	Comfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
Lotrafilcon B / Comfilcon A	Comfilcon A contact lens	Lotrafilcon B multifocal contact lenses worn first, with comfilcon A multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
Comfilcon A /Lotrafilcon B	Lotrafilcon B contact lens	Comfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.

Primary Outcome Measures

Name	Time	Method
Overall Vision	One week of wear	Overall vision, as interpreted by the participant and recorded by the investigator as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being worst and 10 being best.