Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01371539
• Collaborator: (none)
• Enrollment: 109
• Arms: 2
• Duration (Months): 2

Study Details

Study Description

Brief Summary

The purpose of this study was to compare visual performance measures between two multifocal contact lenses on presbyopic wearers.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Presbyopia	Device: Lotrafilcon B contact lens; Device: Comfilcon A contact lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 109 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Lotrafilcon B / Comfilcon A Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.	Device: Lotrafilcon B contact lens; Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use.; Other Names: AIR OPTIX AQUA MULTIFOCAL ; Device: Comfilcon A contact lens; Commercially marketed (France), silicone hydrogel, multifocal contact lens for daily wear use.; Other Names: Biofinity Multifocal
Other: Comfilcon A / Lotrafilcon B Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.	Device: Lotrafilcon B contact lens; Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use.; Other Names: AIR OPTIX AQUA MULTIFOCAL ; Device: Comfilcon A contact lens; Commercially marketed (France), silicone hydrogel, multifocal contact lens for daily wear use.; Other Names: Biofinity Multifocal

Outcome Measures

Primary Outcome Measures

1. Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity [1 week]

   The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.

2. Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity [1 week]

   The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• At least 35 years of age.

• Spectacle add of +0.50 to +2.50 diopters (inclusive).

• Currently wearing soft contact lenses at least 5 days per week and at least 8 hours per day.

• Able to be fit in both eyes with soft multifocal lenses in available powers.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Eye injury or surgery within 12 weeks of enrollment in trial.

• Currently enrolled in any clinical trial.

• Astigmatism of 1.00 diopter or more.

• Currently wearing excluded brands of multifocal lenses, as specified by protocol.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• CIBA VISION

Investigators

• Study Director: Stacie Cummings, O.D., Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CIBA VISION
• ClinicalTrials.gov Identifier: NCT01371539
• Other Study ID Numbers: P-319-C-021
• First Posted: Jun 13, 2011
• Last Update Posted: Aug 3, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by CIBA VISION: Myopia; Presbyopia
• Additional relevant MeSH terms: Myopia; Presbyopia

Study Results

Participant Flow

Recruitment Details	Participants were recruited and enrolled from 12 US private practices.
Pre-assignment Detail	Five participants were enrolled, but not dispensed, due to failing inclusion/exclusion criteria (4) and unacceptable subjective vision (1). Baseline characteristics are presented on all enrolled and dispensed participants: 104.

Arm/Group Title	Lotrafilcon B / Comfilcon A	Comfilcon A / Lotrafilcon B
Arm/Group Description	Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.	Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
Period Title: Period One: One Week
STARTED	53	51
COMPLETED	53	50
NOT COMPLETED	0	1
Period Title: Period One: One Week
STARTED	53	50
COMPLETED	53	47
NOT COMPLETED	0	3

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	All enrolled and dispensed participants
Overall Participants	104
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.0 (6.3)
Sex: Female, Male (Count of Participants)
Female	76 73.1%
Male	28 26.9%
Region of Enrollment (participants) [Number]
United States	104 100%

Outcome Measures

1. Primary Outcome

Title	Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
Description	The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.

Arm/Group Title	Lotrafilcon B	Comfilcon A
Arm/Group Description	Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week.	Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week.
Measure Participants	98	101
Mean (Standard Deviation) [logMAR]	-0.00 (0.07)	0.00 (0.06)

2. Primary Outcome

Title	Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity
Description	The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.

Arm/Group Title	Lotrafilcon B	Comfilcon A
Arm/Group Description	Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week.	Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week.
Measure Participants	98	102
Mean (Standard Deviation) [logMAR]	0.12 (0.10)	0.10 (0.12)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study: 24-JUN-2011 to 16-AUG-2011.
Adverse Event Reporting Description	The safety population included all enrolled and dispensed participants. One participant was dispensed the control product only in this cross-over study.
Arm/Group Title	Lotrafilcon B		Comfilcon A
Arm/Group Description	Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week.		Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week.
All Cause Mortality
	Lotrafilcon B		Comfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lotrafilcon B		Comfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/103 (0%)		0/104 (0%)
Other (Not Including Serious) Adverse Events
	Lotrafilcon B		Comfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/103 (0%)		0/104 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.