Comparison of Two New Silicone Hydrogel Multifocal Products

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

ClinicalTrials.gov Identifier:

NCT00823615

First received: January 13, 2009

Last updated: June 26, 2012

Last verified: January 2012

Purpose

The purpose of this trial is to compare the performance of two multifocal contact lenses.

Condition	Intervention
Presbyopia	Device: Lotrafilcon B multifocal contact lens Device: Senofilcon A multifocal contact lens

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Comparison of Two New Silicone Hydrogel Multifocal Products

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity [ Time Frame: After 1 week of wear ] [ Designated as safety issue: No ]
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.
Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity [ Time Frame: After 1 week of wear ] [ Designated as safety issue: No ]
Tested while reading charts at 40 cm 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.

Enrollment:	40
Study Start Date:	December 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lotrafilcon B / Senofilcon A Lotrafilcon B, followed by Senofilcon A	Device: Lotrafilcon B multifocal contact lens Silicone hydrogel, soft, multifocal contact lens for daily wear use Device: Senofilcon A multifocal contact lens Silicone hydrogel, soft, multifocal contact lens for daily wear use
Senofilcon A / Lotrafilcon B Senofilcon A, followed by Lotrafilcon B	Device: Lotrafilcon B multifocal contact lens Silicone hydrogel, soft, multifocal contact lens for daily wear use Device: Senofilcon A multifocal contact lens Silicone hydrogel, soft, multifocal contact lens for daily wear use

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Requires concurrent ocular medication.
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.
Previous refractive surgery.
Astigmatism > 1.00D.
Currently wearing ACUVUE OASYS for PRESBYOPIA.
Other protocol inclusion/exclusion criteria may apply.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:	NCT00823615 History of Changes
Other Study ID Numbers:	P-319-C-005 sub 7
Study First Received:	January 13, 2009
Results First Received:	September 7, 2010
Last Updated:	June 26, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013