Comparison of Two Soft Bifocal Contact Lenses

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00724945
• Collaborator: (none)
• Enrollment: 113
• Locations: 6
• Arms: 2
• Duration (Months): 1
• Patients Per Site: 18.8
• Patients Per Site Per Month: 18.5

Study Details

Study Description

Brief Summary

The purpose of the study is to compare the visual performance of two soft bifocal contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Device: balafilcon A; Device: senofilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 113 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: senofilcon A / balafilcon A senofilcon A multifocal lenses worn first, balafilcon A multifocal lenses worn second	Device: balafilcon A; multifocal contact lens; Device: senofilcon A; multifocal contact lens
Active Comparator: balafilcon A/senofilcon A balafilcon A multifocal lenses worn first, senofilcon A multifocal lenses worn second	Device: balafilcon A; multifocal contact lens; Device: senofilcon A; multifocal contact lens

Outcome Measures

Primary Outcome Measures

1. Distance Visual Acuity [after 1 week of wear]

   This outcome measures vision while subjects are looking at objects in the distance and is measures in logMARs.logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal

2. Near Visual Acuity [after 1 week wear]

   This outcome measures vision while subjects are looking at objects near to them and is measured in logMARs. logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal.

3. Subject Vision [after 1 week wear]

   Subjects responded to "How would you rate the overall quality of vision with these study contact lenses" using the following scale: 1=poor, 2=fair, 3=good, 4=very good, 5=excellent.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The subject must between 35 and 70 years of age.

• The subject must have presbyopic symptoms or be already wearing presbyopic contact lens correction.

• The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 or -9.00 to -10.00 in each eye.

• Refractive cylinder must be -0.75 D in each eye.

• The subject must have an ADD power of +0.75D to +2.50D in each eye.

• The subject must have best corrected visual acuity of 20/20-3 or better in each eye

• The subject's must have at least 20/30-distance vision OU with the study contact lenses.

• The subject must agree that they are comfortable with their vision prior to being dispensed the study lenses

• The subject must be an adapted soft contact lens wearer in both eyes.

• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

• The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.

Exclusion Criteria:

• Ocular or systemic allergies or disease that may interfere with contact lens wear.

• Systemic disease, autoimmune disease or use of medication, which may interfere with contact lens wear.

• Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear

• Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear.

• Any ocular infection.

• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

• Pregnancy or lactation

• Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).

• History of diabetes

• History of binocular vision abnormality or strabismus

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. James Weber & Associates	Jacksonville	Florida	United States	32205
2	Ted Brink & Associates	Jacksonville	Florida	United States	32256
3		Jacksonville	Florida	United States	32256
4	Eye Associates of Winter Park	Winter Park	Florida	United States	32792
5	Lee Rigel	East Lansing	Michigan	United States	48823
6	Timothy R. Poling, OD	Roanoke	Virginia	United States	24153

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT00724945
• Other Study ID Numbers: CR-1485CK
• First Posted: Jul 30, 2008
• Last Update Posted: May 21, 2015
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Presbyopia

Study Results

Participant Flow

Arm/Group Title	Senofilcon A/Balafilcon A	Balafilcon A/Senofilcon A
Arm/Group Description	senofilcon A multifocal contact lenses worn first, balafilcon A multifocal contact lenses worn second	balafilcon A multifocal contact lenses worn first/ senofilcon A multifocal contact lenses worn second
Period Title: Period 1
STARTED	58	55
COMPLETED	55	54
NOT COMPLETED	3	1
Period Title: Period 1
STARTED	55	54
COMPLETED	51	54
NOT COMPLETED	4	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	The reporting group for baseline characteristics includes all subjects that completed the study wearing contact lenses made from either senofilcon A or balafilcon A material. Excluded are 8 subjects that discontinued and 2 subjects dispensed lenses from outside study contact lens materials.
Overall Participants	103
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.2 (5.9)
Sex: Female, Male (Count of Participants)
Female	87 84.5%
Male	16 15.5%
Region of Enrollment (participants) [Number]
United States	103 100%

Outcome Measures

1. Primary Outcome

Title	Distance Visual Acuity
Description	This outcome measures vision while subjects are looking at objects in the distance and is measures in logMARs.logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal
Time Frame	after 1 week of wear

Outcome Measure Data

Analysis Population Description

Analysis includes participants who completed the study per protocol.

Arm/Group Title	Senofilcon A	Balafilcon A
Arm/Group Description	multifocal contact lens	multifocal contact lens
Measure Participants	103	103
Least Squares Mean (Standard Error) [logMAR units]	-0.08591 (0.008816)	-0.10267 (0.008855)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A
	Comments	Alternative hypothesis: senofilcon A multifocal would be better than or equal to 0.1 logMAR units.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean
	Estimated Value	-0.08591
	Confidence Interval	() 95%; -0.08591 to -0.06857
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.008816
	Estimation Comments

2. Primary Outcome

Title	Near Visual Acuity
Description	This outcome measures vision while subjects are looking at objects near to them and is measured in logMARs. logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal.
Time Frame	after 1 week wear

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Senofilcon A	Balafilcon A
Arm/Group Description	multifocal contact lens	multifocal contact lens
Measure Participants	103	103
Least Squares Mean (Standard Error) [logMAR units]	0.02711 (0.008816)	0.01933 (0.008861)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A
	Comments	Alternative hypothesis: senofilcon A multifocal lens would be better than or equal to 0.17 logMAR units.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean
	Estimated Value	0.02711
	Confidence Interval	() 97.5%; 0.02711 to 0.04445
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.008816
	Estimation Comments

3. Primary Outcome

Title	Subject Vision
Description	Subjects responded to "How would you rate the overall quality of vision with these study contact lenses" using the following scale: 1=poor, 2=fair, 3=good, 4=very good, 5=excellent.
Time Frame	after 1 week wear

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Senofilcon A	Balafilcon A
Arm/Group Description	multifocal contact lens	multifocal contact lens
Measure Participants	103	103
Least Squares Mean (Standard Error) [Scores on a scale]	3.4594 (0.09926)	3.3853 (0.09926)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Balafilcon A
	Comments	Alternative hypothesis: senofilcon A multifocal lens will have subjective vision that is non-inferior to balafilcon A multifocal.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is -0.5.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.07407
	Confidence Interval	() 97.5%; -0.1797 to 0.07407
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.1279
	Estimation Comments	Mean difference was calculated as senofilcon A multifocal minus balafilcon A multifocal.

Adverse Events

Arm/Group Title	Senofilcon A/Balafilcon A		Balafilcon A/Senofilcon A
Arm/Group Description	senofilcon A multifocal contact lenses worn first, balafilcon A multifocal contact lenses worn second		balafilcon A multifocal contact lenses worn first/ senofilcon A multifocal contact lenses worn second
All Cause Mortality
	Senofilcon A/Balafilcon A		Balafilcon A/Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Senofilcon A/Balafilcon A		Balafilcon A/Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/55 (0%)
Other (Not Including Serious) Adverse Events
	Senofilcon A/Balafilcon A		Balafilcon A/Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/55 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.