Comparison of Two New Silicone Hydrogel Multifocal Products

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00823615
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Duration (Months): 2

Study Details

Study Description

Brief Summary

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

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of Two New Silicone Hydrogel Multifocal Products
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: 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
Other: 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

Outcome Measures

Primary Outcome Measures

1. 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.

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

   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.

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

• Best-corrected 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 (-0.50 to -5.50D).

• Currently wearing soft contact lenses at least 5 days a week.

• Other protocol inclusion/exclusion criteria may apply.

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

Locations

No locations specified.

Sponsors and Collaborators

• CIBA VISION

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CIBA VISION
• ClinicalTrials.gov Identifier: NCT00823615
• Other Study ID Numbers: P-319-C-005 sub 7
• First Posted: Jan 15, 2009
• Last Update Posted: Jun 29, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Presbyopia

Study Results

Participant Flow

Pre-assignment Detail	Two participants were enrolled but not dispensed due to failing inclusion criteria. These participants were included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.

Arm/Group Title	Lotrafilcon B / Senofilcon A	Senofilcon A / Lotrafilcon B
Arm/Group Description	Lotrafilcon B multifocal contact lens worn first, followed by Senofilcon A multifocal contact lens worn second. Both products were worn on a daily-wear basis.	Senofilcon A multifocal contact lens worn first, followed by Lotrafilcon B multifocal contact lens worn second. Both products were worn on a daily-wear basis.
Period Title: Period 1
STARTED	19	19
COMPLETED	19	19
NOT COMPLETED	0	0
Period Title: Period 1
STARTED	19	19
COMPLETED	16	17
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	This reporting group includes all enrolled and dispensed subjects
Overall Participants	38
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.6 (4.7)
Sex: Female, Male (Count of Participants)
Female	30 78.9%
Male	8 21.1%

Outcome Measures

1. Primary Outcome

Title	Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
Description	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.
Time Frame	After 1 week of wear

Outcome Measure Data

Analysis Population Description

Per protocol. Analysis excluded major protocol deviations as determined by masked review.

Arm/Group Title	Lotrafilcon B Multifocal Contact Lens	Senofilcon A Multifocal Contact Lens
Arm/Group Description	Silicone hydrogel, soft, multifocal contact lens	Silicone hydrogel, soft, multifocal contact lens
Measure Participants	33	33
Mean (Standard Deviation) [LogMAR]	-0.08 (0.04)	-0.04 (0.06)

2. Primary Outcome

Title	Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity
Description	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.
Time Frame	After 1 week of wear

Outcome Measure Data

Analysis Population Description

Per protocol. Analysis excluded major protocol deviations as determined by masked review.

Arm/Group Title	Lotrafilcon B Multifocal Contact Lens	Senofilcon A Multifocal Contact Lens
Arm/Group Description	Silicone hydrogel, soft, multifocal contact lens	Silicone hydrogel, soft, multifocal contact lens
Measure Participants	33	33
Mean (Standard Deviation) [LogMAR]	0.05 (0.11)	0.10 (0.14)

Adverse Events

Time Frame	9 weeks, duration of the study
Adverse Event Reporting Description	1 week of wear for each intervention
Arm/Group Title	Lotrafilcon B Multifocal Contact Lens		Senofilcon A Multifocal Contact Lens
Arm/Group Description	Silicone hydrogel, soft, multifocal contact lens		Silicone hydrogel, soft, multifocal contact lens
All Cause Mortality
	Lotrafilcon B Multifocal Contact Lens		Senofilcon A Multifocal Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lotrafilcon B Multifocal Contact Lens		Senofilcon A Multifocal Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/38 (0%)
Other (Not Including Serious) Adverse Events
	Lotrafilcon B Multifocal Contact Lens		Senofilcon A Multifocal Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/38 (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 pre-clinical and/or clinical data or impressions from this trial.