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

NCT01371539 | Completed Results

• 1 other identifier: P-319-C-021
• Study Type: interventional
• Target: 109
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Myopia; Presbyopia

Keywords

Myopia; Presbyopia

Outcome Measures

Primary Outcomes (2)

• Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity

  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.

  1 week

• Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity

  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.

  1 week

Study Arms (2)

Lotrafilcon B / Comfilcon A

OTHER

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.

Device: Lotrafilcon B contact lens; Device: Comfilcon A contact lens

Comfilcon A / Lotrafilcon B

OTHER

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.

Device: Lotrafilcon B contact lens; Device: Comfilcon A contact lens

Interventions

Lotrafilcon B contact lens DEVICE

Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use.

Also known as: AIR OPTIX AQUA MULTIFOCAL

Comfilcon A / Lotrafilcon B; Lotrafilcon B / Comfilcon A

Comfilcon A contact lens DEVICE

Commercially marketed (France), silicone hydrogel, multifocal contact lens for daily wear use.

Also known as: Biofinity Multifocal

Comfilcon A / Lotrafilcon B; Lotrafilcon B / Comfilcon A

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CIBA VISION: lead

MeSH Terms

Conditions

Myopia; Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Stacie Cummings, O.D.
• Organization: Alcon Research, Ltd.

1-800-241-7629

Study Officials

• Stacie Cummings, O.D.

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 13, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 3, 2012
• Results First Posted: August 3, 2012

Record last verified: 2012-06