Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00909792
• Collaborator: (none)
• Enrollment: 259
• Arms: 2
• Duration (Months): 1

Study Details

Study Description

Brief Summary

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

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 259 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

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

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.

Eligibility Criteria

Criteria

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

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.

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: NCT00909792
• Other Study ID Numbers: P-319-C-013
• First Posted: May 28, 2009
• Last Update Posted: Jun 29, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Presbyopia

Study Results

Participant Flow

Pre-assignment Detail	One participant was enrolled but not dispensed due to failing inclusion/exclusion criteria. This participant is 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 lenses worn first, with Senofilcon A multifocal contact lenses worn second. Both products worn in a daily wear basis.	Senofilcon A multifocal contact lenses worn first, with Lotrafilcon B multifocal contact lenses worn second. Both products worn in a daily wear basis.
Period Title: Period 1
STARTED	130	128
COMPLETED	130	127
NOT COMPLETED	0	1
Period Title: Period 1
STARTED	129	125
COMPLETED	128	124
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	This reporting group includes all enrolled and dispensed subjects.
Overall Participants	258
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	45.5 (4.3)
Sex: Female, Male (Count of Participants)
Female	222 86%
Male	36 14%

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	237	234
Mean (Standard Deviation) [logMAR]	-0.01 (0.06)	0.01 (0.07)

Adverse Events

Time Frame	46 days, duration of the study.
Arm/Group Title	Lotrafilcon B		Senofilcon A
Arm/Group Description	Silicone hydrogel, soft, multifocal contact lens		Silicone hydrogel, soft, multifocal contact lens
All Cause Mortality
	Lotrafilcon B		Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lotrafilcon B		Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/256 (0%)		0/258 (0%)
Other (Not Including Serious) Adverse Events
	Lotrafilcon B		Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/256 (0%)		0/258 (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.