Clinical Performance Comparison of Two Contact Lenses

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00975585
• Collaborator: Visioncare Research Ltd. (Other)
• Enrollment: 379
• Locations: 25
• Arms: 2
• Actual Duration (Months): 2
• Patients Per Site: 15.2
• Patients Per Site Per Month: 7.6

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the clinical performance of two contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: senofilcon A; Device: lotrafilcon B	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 379 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Two Silicone Hydrogel Frequent Replacement Contact Lenses
• Actual Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: senofilcon A both eyes soft contact lens worn daily for 2 weeks, with a 2-week replacement regimen.	Device: senofilcon A; soft contact lens, 2-week replacement indicated
Active Comparator: lotrafilcon B both eyes soft contact lens worn daily for 4 weeks, with a 4-week replacement regimen	Device: lotrafilcon B; soft contact lens with a 4-week replacement indicated.

Outcome Measures

Primary Outcome Measures

1. Average Corneal Staining [2 weeks]

   The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe.

2. Visual Acuity [2 weeks]

   Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.

3. Overall Comfort [2 weeks]

   After two weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (senofilcon A and lotrafilcon B) using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

4. Overall Comfort [2 weeks and 4 weeks]

   After four weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (lotrafilcon B)using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

Secondary Outcome Measures

1. Limbal Redness [2 weeks]

   The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe

2. Bulbar Redness [2 weeks]

   The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe

3. Symptoms of Dryness [2 weeks]

   Subjects responded to a phone survey question regarding the frequency of the sensation of dryness while wearing the study contact lenses using the following scale: 1=Extreme, 2=Moderate, 3=Slight, 4=None

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Existing daily soft lens wearer.

• Require a distance visual correction in both eyes.

• Have a contact lens spherical distance refraction between -1.00D and -6.00D.

• Have refractive astigmatism less than or equal to 1.00D in both eyes.

• Achieve 20/30 or better corrected distance acuity.

• Have normal eyes with no evidence of abnormality or disease.

Exclusion Criteria:

• Requires presbyopic correction.

• Requires ocular medications.

• Grade 3 or 4 ocular abnormalities.

• Grade 3 corneal staining in more than one region.

• Has had refractive surgery.

• Any other injury or ocular surgery within 8 weeks prior to study enrollment.

• Has abnormal lacrimal secretions.

• Pre-existing ocular irritation that would preclude contact lens fitting.

• Has keratoconus or other corneal irregularity.

• Polymethyl methacrylate (PMMA), Hybrid or Rigid Gas Permeable (RGP) wear in the previous 8 weeks.

• Wears habitual contact lenses that are toric, multifocal or worn extended wear.

• Any systemic illness which would contraindicate lens wear or the medical treatment of would affect vision or successful lens wear.

• Diabetic.

• Infectious or immunosuppressive disease.

• History of chronic eye disease (e.g glaucoma or age related macular degeneration).

• Pregnancy, lactation or planning pregnancy at time of enrollment.

• Participation in any concurrent clinical trial or in another trial in the last 30 days.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		North Little Rock	Arkansas	United States	72116
2		Campbell	California	United States	95008
3		Colorado Springs	Colorado	United States	80909
4		Jacksonville	Florida	United States	32205
5		Jacksonville	Florida	United States	32256
6		Miami	Florida	United States	33155
7		Winter Park	Florida	United States	32792
8		Roswell	Georgia	United States	30076
9		Boston	Massachusetts	United States	02114
10		Cambridge	Massachusetts	United States	02140
11		Blue Springs	Missouri	United States	64015
12		New York	New York	United States	10001
13		Chagrin Falls	Ohio	United States	44023
14		North Olmsted	Ohio	United States	44070
15		Warren	Ohio	United States	44484
16		State College	Pennsylvania	United States	16801
17		Warwick	Rhode Island	United States	02888
18		Chamberlain	South Dakota	United States	57325
19		Hot Springs	South Dakota	United States	57747
20		Bartlett	Tennessee	United States	38134
21		Brentwood	Tennessee	United States	37027
22		Memphis	Tennessee	United States	38119
23		Tyler	Texas	United States	757703
24		Burlington	Vermont	United States	05401
25		West Allis	Wisconsin	United States	53227

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.
• Visioncare Research Ltd.

Investigators

• Study Director: Sheila, B Hickson-Curran, BSc, MCOptom, Johnson & Johnson Vision Care, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT00975585
• Other Study ID Numbers: CR-0907; PHNX-518
• First Posted: Sep 11, 2009
• Last Update Posted: Jun 19, 2018
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Senofilcon A	Lotrafilcon B
Arm/Group Description	contact lens	contact lens
Period Title: Overall Study
STARTED	184	195
COMPLETED	177	183
NOT COMPLETED	7	12

Baseline Characteristics

Arm/Group Title	Senofilcon A	Lotrafilcon B	Total
Arm/Group Description	contact lens	contact lens	Total of all reporting groups
Overall Participants	184	195	379
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.7 (7.0)	29.3 (6.9)	29.5 (6.9)
Sex: Female, Male (Count of Participants)
Female	125 67.9%	136 69.7%	261 68.9%
Male	59 32.1%	59 30.3%	118 31.1%
Region of Enrollment (participants) [Number]
United States	184 100%	195 100%	379 100%

Outcome Measures

1. Primary Outcome

Title	Average Corneal Staining
Description	The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Analysis included all subjects that completed the study.

Arm/Group Title	Senofilcon A	Lotrafilcon B
Arm/Group Description	contact lens	contact lens
Measure Participants	177	183
Least Squares Mean (Standard Error) [units on a scale]	0.157 (0.018)	0.170 (0.018)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Lotrafilcon B
	Comments	The alternative hypothesis is that senofilcon A contact lenses have non-inferior (less than or equal to) average corneal staining than lotrafilcon B after two weeks of wear.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Margin = 0.5
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.014
	Confidence Interval	(2-Sided) 97.46%; -0.058 to 0.031
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.020
	Estimation Comments	The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis is adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.

2. Primary Outcome

Title	Visual Acuity
Description	Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Senofilcon A	Lotrafilcon B
Arm/Group Description	contact lens	contact lens
Measure Participants	177	183
Least Squares Mean (Standard Error) [logMAR units]	-0.012 (0.003)	-0.002 (0.003)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Lotrafilcon B
	Comments	The alternative hypothesis is that senofilcon A contact lenses are non-inferior (less than or equal to)in visual acuity to lotrafilcon B contact lenses after two weeks of wear.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Margin = 0.25
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.010
	Confidence Interval	(2-Sided) 97.46%; -0.021 to -0.010
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.005
	Estimation Comments	The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.

3. Primary Outcome

Title	Overall Comfort
Description	After two weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (senofilcon A and lotrafilcon B) using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Analysis includes subjects that completed the study.

Arm/Group Title	Senofilcon A	Lotrafilcon B
Arm/Group Description	contact lens	contact lens
Measure Participants	177	183
Least Squares Mean (Standard Error) [units on a scale]	3.938 (0.090)	3.536 (0.091)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Lotrafilcon B
	Comments	The alternative hypothesis is that senofilcon A contact lenses have a higher rating of overall comfort than lotrafilcon B after two weeks of wear.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.402
	Confidence Interval	(2-Sided) 97.46%; 0.117 to 0.402
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.127
	Estimation Comments	The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject as random effects.

4. Primary Outcome

Title	Overall Comfort
Description	After four weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (lotrafilcon B)using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Time Frame	2 weeks and 4 weeks

Outcome Measure Data

Analysis Population Description

Analysis includes all subjects that completed the study.

Arm/Group Title	Lotrafilcon B at 2 Weeks	Lotrafilcon B at 4 Weeks
Arm/Group Description	lotrafilcon B contact lens after two weeks of wear	lotrafilcon B contact lens after four weeks of wear
Measure Participants	183	183
Least Squares Mean (Standard Error) [units on a scale]	3.534 (0.111)	3.436 (0.118)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Lotrafilcon B
	Comments	The alternative hypothesis is that lotrafilcon B contact lenses have a lower rating of overall comfort after 4 weeks of wear compared to after 2 weeks of wear.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.098
	Confidence Interval	(2-Sided) 97.46%; -0.218 to 0.098
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.141
	Estimation Comments	The mean difference is lotrafilcon B at 2 weeks minus lotrafilcon B at 4 weeks. Analysis adjusted for duration of wear, stie, duration of wear by site interaction as fixed effects, subject as random effects.

5. Secondary Outcome

Title	Limbal Redness
Description	The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Analysis includes subjects that completed the study.

Arm/Group Title	Senofilcon A	Lotrafilcon B
Arm/Group Description	contact lens	contact lens
Measure Participants	177	183
Least Squares Mean (Standard Error) [units on a scale]	0.376 (0.031)	0.499 (0.030)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Lotrafilcon B
	Comments	The alternative hypothesis is that senofilcon A contact lenses are non-inferior in limbal redness 5 to lotrafilcon B contact lenses after two weeks of wear.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Margin = 0.5
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.123
	Confidence Interval	(2-Sided) 98.2%; -0.123 to -0.051
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.030
	Estimation Comments	The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.

6. Secondary Outcome

Title	Bulbar Redness
Description	The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Analysis includes subjects that completed the study.

Arm/Group Title	Senofilcon A	Lotrafilcon B
Arm/Group Description	contact lens	contact lens
Measure Participants	177	183
Least Squares Mean (Standard Error) [units on a scale]	0.465 (0.031)	0.532 (0.030)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Lotrafilcon B
	Comments	The alternative hypothesis is that senofilcon A contact lenses are non-inferior in bulbar redness to lotrafilcon B contact lenses after two weeks of wear.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Margin = 0.5
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.068
	Confidence Interval	(2-Sided) 98.2%; -0.068 to 0.008
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.032
	Estimation Comments	The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.

7. Secondary Outcome

Title	Symptoms of Dryness
Description	Subjects responded to a phone survey question regarding the frequency of the sensation of dryness while wearing the study contact lenses using the following scale: 1=Extreme, 2=Moderate, 3=Slight, 4=None
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Analysis includes subjects that completed the study.

Arm/Group Title	Senofilcon A	Lotrafilcon B
Arm/Group Description	contact lens	contact lens
Measure Participants	177	183
Least Squares Mean (Standard Error) [units on a scale]	2.003 (0.087)	2.414 (0.088)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Lotrafilcon B
	Comments	The alternative hypothesis is that senofilcon A contact lenses have less frequency of dryness than lotrafilcon B contact lenes after two weeks of wear.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.411
	Confidence Interval	(2-Sided) 98.2%; -0.411 to -0.117
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.124
	Estimation Comments	The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by stie interaction as fixed effects, subject as random effects.

Adverse Events

Arm/Group Title	Senofilcon A		Lotrafilcon B
Arm/Group Description	contact lens		contact lens
All Cause Mortality
	Senofilcon A		Lotrafilcon B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Senofilcon A		Lotrafilcon B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/184 (0%)		0/195 (0%)
Other (Not Including Serious) Adverse Events
	Senofilcon A		Lotrafilcon B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/184 (0%)		0/195 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Prior to submission for publication or presentation, the PI will provide SPONSOR with at least sixty (60) days for review of a manuscript. Notwithstanding the foregoing, no paper that incorporates SPONSOR Confidential Information will be submitted for publication without SPONSOR's prior written consent. If requested in writing, the PI will withhold such publication for up to an additional sixty (60) days to allow for filing of a patent application.