Comparison of Two Multifocal Contact Lenses

NCT01250054 | Completed Results

• 1 other identifier: P-319-C-018
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Overall Vision

  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.

  One week of wear

Study Arms (2)

Lotrafilcon B / Comfilcon A

OTHER

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.

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

Comfilcon A /Lotrafilcon B

OTHER

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.

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 (Europe), 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.
• 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.

You may not qualify if:

• Eye injury or surgery within twelve weeks of enrollment.
• Currently enrolled in any clinical trial.
• Astigmatism \> 1.00D.
• Strabismus/amblyopia.

Sponsors & Collaborators

• CIBA VISION: lead

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Joe Rappon, OD, MS, FAAO / Head, Clinical Trial Management
• Organization: CIBA VISION

Joseph.Rappon@cibavision.com

1-678-415-3343

Publication Agreements

• PI is Sponsor Employee: 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: November 29, 2010
• First Posted: November 30, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 29, 2012
• Results First Posted: August 12, 2011

Record last verified: 2011-07