Clinical Assessment of a Multifocal Contact Lens for People Who Use Reading Glasses Only

NCT01268501 | Completed Results

• 1 other identifier: P-319-C-019
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this trial is to evaluate the use of multifocal contact lenses in people who use reading glasses only.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Overall Convenience With Contact Lenses

  Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, "very satisfied" or "satisfied."

  3 weeks of wear

Study Arms (1)

Lotrafilcon B multifocal

EXPERIMENTAL

Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis

Device: Lotrafilcon B multifocal contact lens

Interventions

Lotrafilcon B multifocal contact lens DEVICE

Commercially marketed, silicone hydrogel, multifocal, soft contact lenses FDA-approved for up to 4 weeks recommended replacement schedule and up to 6 nights of extended (overnight) wear.

Also known as: AIR OPTIX® AQUA MULTIFOCAL

Lotrafilcon B multifocal

Eligibility Criteria

• Age: 40 Years - 48 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Is between 40 and 48 years of age (inclusive).
• Has read and signed the Informed Consent.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Wears reading spectacles for close work.

You may not qualify if:

• Eye injury or surgery within twelve weeks of enrollment.
• Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions.
• Currently enrolled in a clinical trial.
• Has worn contact lenses previously.

Sponsors & Collaborators

• CIBA VISION: lead

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Director of Alcon Clinical
• Organization: Alcon Research, Ltd.

1-800-241-7629

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2010
• First Posted: December 31, 2010
• Study Start: December 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: June 29, 2012
• Results First Posted: February 9, 2012

Record last verified: 2012-02