Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: Lotrafilcon B; Device: Senofilcon A

• Study Type: Interventional
• Enrollment (Actual): 259
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be at least 35 years of age
• Best-corrected distance visual acuity of at least 20/40 in each eye.
• Spectacle add between +0.75D and +1.50D (inclusive).
• Able to be fit in available study sphere powers (-1.00 to -5.00D)
• Currently wearing soft contact lenses at least 5 days a week.
• Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

• Eye injury or surgery within twelve weeks immediately prior to enrollment.
• Currently enrolled in an ophthalmic clinical trial.
• Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
• Astigmatism ≥ 1.00D.
• Currently wearing either of the study products.
• Other protocol inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lotrafilcon B / Senofilcon A; Lotrafilcon B, followed by Senofilcon A	Device: Lotrafilcon B; Silicone hydrogel, soft, multifocal contact lens; Device: Senofilcon A; Silicone hydrogel, soft, multifocal contact lens
Other: Senofilcon A / Lotrafilcon B; Senofilcon A, followed by Lotrafilcon B	Device: Lotrafilcon B; Silicone hydrogel, soft, multifocal contact lens; Device: Senofilcon A; Silicone hydrogel, soft, multifocal contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity	Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.	After 1 week of wear

Collaborators and Investigators

• Sponsor: CIBA VISION

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: May 27, 2009
• First Submitted That Met QC Criteria: May 27, 2009
• First Posted (Estimate): May 28, 2009

Study Record Updates

• Last Update Posted (Estimate): June 29, 2012
• Last Update Submitted That Met QC Criteria: June 26, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: P-319-C-013