Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01244516
• Collaborator: (none)
• Enrollment: 540
• Locations: 35
• Arms: 3
• Actual Duration (Months): 2
• Patients Per Site: 15.4
• Patients Per Site Per Month: 7.7

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the clinical performance of three silicone hydrogel contact lenses over a 2 week period.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: galyfilcon A, BC 8.30; Device: lotrafilcon B, BC 8.60; Device: comfilcon A, BC 8.60	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 540 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Actual Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: galyfilcon A Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.	Device: galyfilcon A, BC 8.30; galyfilcon A, BC 8.30 soft contact lens
Other: lotrafilcon B Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.	Device: lotrafilcon B, BC 8.60; lotrafilcon B, BC 8.60 soft contact lens
Other: comfilcon A Subjects that were randomized to wear comfilcon A lens throughout the course of the study.	Device: comfilcon A, BC 8.60; comfilcon A, BC 8.60 soft contact lens

Outcome Measures

Primary Outcome Measures

1. Overall Subjective Comfort [after 2 weeks of contact lens wear]

   Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

2. Corneal Staining [after 2 weeks of contact lens wear]

   Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated.

Secondary Outcome Measures

1. Overall Subjective Lens Handling [after 2 weeks of contact lens wear]

   Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. Only galyficlon A and comfilcon A were evaluated.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Be no less than 18 and no more than 39 years of age.

• Sign Written Informed Consent and investigator to record this on Case Report Form.

• Be willing and able to adhere to the instructions set out in the protocol.

• Be an existing successful daily wear soft contact lens wearer. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month.

• No extended wear in the last 3 months.

• Subjective refraction must result in a vertex corrected spherical contact lens prescription between -1.00 and -6.00 diopters.

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

• Achieve visual acuity of 6/9 (20/30) or better in each eye.

• Require a visual correction in both eyes (no monovision allowed).

• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: no amblyopia, no evidence of lid abnormality or infection (including blepharitis/meibomitis), no conjunctival abnormality or infection, no clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities), no other active ocular disease.

Exclusion Criteria:

• Requires concurrent ocular medication.

• Clinically significant corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.

• Clinically significant corneal staining

• Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00 diopters).

• Has had refractive surgery.

• Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.

• Abnormal lacrimal secretions.

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

• Keratoconus or other corneal irregularity.

• Hard, hybrid or Rigid Gas Permeable lens wear in the previous 8 weeks.

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

• Diabetic.

• Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease [e.g., Human immunodeficiency virus (HIV)].

• History of chronic eye disease (e.g. glaucoma or Age Related Macular Degeneration).

• Pregnancy, lactating or planning a pregnancy at the time of enrollment.

• Participation in any concurrent clinical trial or in last 30 days

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Brea	California	United States	92891
2		Campbell	California	United States	95008
3		Cupertino	California	United States	95014
4		Mission Viejo	California	United States	92691
5		Colorado Springs	Colorado	United States	80909
6		Bridgeport	Connecticut	United States	06610
7		Aventura	Florida	United States	33180
8		Jacksonville	Florida	United States	32256
9		Tallahassee	Florida	United States	32308
10		Tampa	Florida	United States	33625
11		Winter Park	Florida	United States	32792
12		Roswell	Georgia	United States	30076
13		Bloomington	Illinois	United States	61701
14		Mishawaka	Indiana	United States	46545
15		Pittsburg	Kansas	United States	66763
16		Boston	Massachusetts	United States	02114
17		Independence	Missouri	United States	64055
18		Raytown	Missouri	United States	64133
19		Closter	New Jersey	United States	07624
20		New York	New York	United States	10001
21		Raleigh	North Carolina	United States	27615
22		North Olmsted	Ohio	United States	44070
23		Powell	Ohio	United States	43065
24		Kittanning	Pennsylvania	United States	16201
25		Warwick	Rhode Island	United States	02888
26		Chamberlain	South Dakota	United States	57325
27		Bartlett	Tennessee	United States	38134
28		Brentwood	Tennessee	United States	37027
29		Memphis	Tennessee	United States	38119
30		Tyler	Texas	United States	75701
31		Tyler	Texas	United States	75703
32		Salt Lake City	Utah	United States	84106
33		Burlington	Vermont	United States	05401
34		Salem	Virginia	United States	24153
35		Virginia Beach	Virginia	United States	23455

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: NCT01244516
• Other Study ID Numbers: CR-201007
• First Posted: Nov 19, 2010
• Last Update Posted: Jun 19, 2018
• Last Verified: Apr 1, 2018

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	There were thirty-five sites recruited in the US. There were 540 subjects recruited with 520 enrolled and randomized. The study was a 2-week, randomized, single-masked (subjects), parallel arm, bilateral dispensing study. The subject group was expected to be representative of a cross-section of the population within the US contact lens market.
Pre-assignment Detail	There were 20 subjects who did not meet the inclusion or did meet the exclusion criteria. There were 10 screen failures and 10 who wore spectacles to baseline visit invoking the exclusion criteria.

Arm/Group Title	Galyfilcon A	Lotrafilcon B	Comfilcon A
Arm/Group Description	Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.	Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.	Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
Period Title: Period 1 (Baseline to 1-week Visit)
STARTED	170	177	173
COMPLETED	166	171	170
NOT COMPLETED	4	6	3
Period Title: Period 1 (Baseline to 1-week Visit)
STARTED	166	171	170
COMPLETED	163	170	168
NOT COMPLETED	3	1	2

Baseline Characteristics

Arm/Group Title	Galyfilcon A	Lotrafilcon B	Comfilcon A	Total
Arm/Group Description	Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.	Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.	Subjects that were randomized to wear comfilcon A lens throughout the course of the study.	Total of all reporting groups
Overall Participants	163	170	168	501
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.8 (5.9)	28.3 (5.6)	27.4 (5.7)	28.2 (5.7)
Sex: Female, Male (Count of Participants)
Female	108 66.3%	118 69.4%	115 68.5%	341 68.1%
Male	55 33.7%	52 30.6%	53 31.5%	160 31.9%
Region of Enrollment (Count of Participants)
United Kingdom	163 100%	170 100%	168 100%	501 100%

Outcome Measures

1. Primary Outcome

Title	Overall Subjective Comfort
Description	Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Time Frame	after 2 weeks of contact lens wear

Outcome Measure Data

Analysis Population Description

Analysis is on those subjects who completed the study (n=501).

Arm/Group Title	Galyfilcon A	Lotrafilcon B	Comfilcon A
Arm/Group Description	Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.	Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.	Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
Measure Participants	163	170	168
Least Squares Mean (Standard Error) [CLUE score]	51.7 (2.1)	51.3 (2.0)	51.3 (2.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Galyfilcon A, Lotrafilcon B
	Comments	This comparison is between galyfilcon and lotrafilcon B. Ho: galyfilcon A -lotrafilcon B <= -5. Ha: galyfilcon A - lotrafilcon B > -5.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is set at -5.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.39
	Confidence Interval	(2-Sided) 97.4%; -5.91 to 6.70
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.83
	Estimation Comments	The direction of comparison is AAHP - AOA.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Galyfilcon A, Comfilcon A
	Comments	This comparison is between galyfilcon A and comfilcon A. Ho: gayfilcon A- comfilcon A <= -5. Ha: galyfilcon A- comfilcon A> -5.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is set at -5.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.42
	Confidence Interval	(2-Sided) 97.4%; -5.96 to 6.79
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.79
	Estimation Comments	The direction of comparison is AAHP - BIO.

2. Primary Outcome

Title	Corneal Staining
Description	Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated.
Time Frame	after 2 weeks of contact lens wear

Outcome Measure Data

Analysis Population Description

Analysis is on those subjects who completed the study (n=501).

Arm/Group Title	Galyfilcon A	Lotrafilcon B	Comfilcon A
Arm/Group Description	Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.	Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.	Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
Measure Participants	163	170	168
Measure Eyes	326	340	336
No corneal staining	78.5	67.1	66.1
With corneal staining	21.5	32.9	33.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Galyfilcon A, Lotrafilcon B
	Comments	The comparison is between galyfilcon A (AAHP) and lotrafilcon B (AOA) for comparing proportions of those with corneal staining and those without. Ho: OR = 1 for (AAHP/AOA). Ha: OR > 1 for (AAHP/AOA).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is set at > 0.75. Superiority is concluded is the 97.4% CL > 1.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.66
	Confidence Interval	(2-Sided) 97.4%; 1.14 to 2.44
	Parameter Dispersion	Type: Value:
	Estimation Comments	The direction of comparison is AAHP/AOA.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Galyfilcon A, Comfilcon A
	Comments	The comparison is between galyfilcon A (AAHP) and comfilcon A (BIO) for comparing proportions of those with corneal staining and those without. Ho: OR = 1 for (AAHP/BIO). Ha: OR > 1 for (AAHP/BIO).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is set at > 0.75. Superiority is concluded is the 97.4% CL > 1.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.66
	Confidence Interval	(2-Sided) 97.4%; 1.14 to 2.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Overall Subjective Lens Handling
Description	Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. Only galyficlon A and comfilcon A were evaluated.
Time Frame	after 2 weeks of contact lens wear

Outcome Measure Data

Analysis Population Description

Analysis is on those subjects who completed the study (n=331) and where assigned to these two arms. Analysis is restricted to these two arms for this outcome as specified per protocol.

Arm/Group Title	Galyfilcon A	Comfilcon A
Arm/Group Description	Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.	Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
Measure Participants	163	168
Least Squares Mean (Standard Error) [CLUE score]	64.3 (1.6)	59.8 (1.6)

Adverse Events

Arm/Group Title	Galyfilcon A		Lotrafilcon B		Comfilcon A
Arm/Group Description	Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.		Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.		Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
All Cause Mortality
	Galyfilcon A		Lotrafilcon B		Comfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Galyfilcon A		Lotrafilcon B		Comfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/170 (0%)		0/177 (0%)		0/173 (0%)
Other (Not Including Serious) Adverse Events
	Galyfilcon A		Lotrafilcon B		Comfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/170 (0%)		0/177 (0%)		0/173 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Publication required agreement and written authorization from the Sponsor.