Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: Lotrafilcon B; Device: Senofilcon A

• Registration Number: NCT00909792
• Lead Sponsor: CIBA VISION

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-27
• Study First Submitted QC: 2009-05-27
• Study First Posted: 2009-05-28
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2010-09-16
• Results First Submitted QC: 2010-10-06
• Results First Posted: 2010-10-29
• Status Verified: 2012-01
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 259

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lotrafilcon B / Senofilcon A	Lotrafilcon B	Lotrafilcon B, followed by Senofilcon A
Lotrafilcon B / Senofilcon A	Senofilcon A	Lotrafilcon B, followed by Senofilcon A
Senofilcon A / Lotrafilcon B	Lotrafilcon B	Senofilcon A, followed by Lotrafilcon B
Senofilcon A / Lotrafilcon B	Senofilcon A	Senofilcon A, followed by Lotrafilcon B

Primary Outcome Measures

Name	Time	Method
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity	After 1 week of wear	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.