Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials

Not Applicable

Completed

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

• Registration Number: NCT01371539
• Lead Sponsor: CIBA VISION

Brief Summary

The purpose of this study was to compare visual performance measures between two multifocal contact lenses on presbyopic wearers.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-13
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-06
• Results First Submitted: 2012-06-28
• Results First Submitted QC: 2012-06-28
• Last Update Submitted: 2012-06-28
• Results First Posted: 2012-08-03
• Last Update Posted: 2012-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• At least 35 years of age.
• Spectacle add of +0.50 to +2.50 diopters (inclusive).
• Currently wearing soft contact lenses at least 5 days per week and at least 8 hours per day.
• Able to be fit in both eyes with soft multifocal lenses in available powers.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Eye injury or surgery within 12 weeks of enrollment in trial.
• Currently enrolled in any clinical trial.
• Astigmatism of 1.00 diopter or more.
• Currently wearing excluded brands of multifocal lenses, as specified by protocol.
• 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 contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
Lotrafilcon B / Comfilcon A	Comfilcon A contact lens	Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
Comfilcon A / Lotrafilcon B	Lotrafilcon B contact lens	Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
Comfilcon A / Lotrafilcon B	Comfilcon A contact lens	Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.

Primary Outcome Measures

Name	Time	Method
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity	1 week	The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.
Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity	1 week	The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.