Pilot Evaluation of a New Galyfilcon A Contact Lens Compared to a Marketed Galyfilcon A Contact Lens

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01094730
• Collaborator: (none)
• Enrollment: 185
• Locations: 9
• Arms: 2
• Actual Duration (Months): 1.9
• Patients Per Site: 20.6
• Patients Per Site Per Month: 10.6

Study Details

Study Description

Brief Summary

The purpose of this study is to compare lens surface characteristics and comfort between an experimental contact lens and a marketed contact lens.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: galyfilcon A prototype lens; Device: marketed galyfilcon A lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 185 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multi-site Dispensing Evaluation Comparing a New Galyfilcon A Prototype Lens With a Marketed Galyfilcon A Contact Lens
• Actual Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: galyfilcon A prototype/marketed galyfilcon A The galyfilcon A prototype lens worn daily for 12-16 days during the first period then the marketed galyfilcon A lens worn daily for 12-16 days during the second period.	Device: galyfilcon A prototype lens; Experimental silicone hydrogel contact lens; Device: marketed galyfilcon A lens; Marketed silicone hydrogel contact lens.; Other Names: ACUVUE(R) ADVANCE(TM)
Other: marketed galyfilcon A/galyfilcon A prototype The marketed galyfilcon A lens worn daily for 12-16 days during the first period then the galyfilcon A prototype lens worn daily for 12-16 days during the second period; during each period.	Device: galyfilcon A prototype lens; Experimental silicone hydrogel contact lens; Device: marketed galyfilcon A lens; Marketed silicone hydrogel contact lens.; Other Names: ACUVUE(R) ADVANCE(TM)

Outcome Measures

Primary Outcome Measures

1. Lens Front Surface Deposits at Day 7 [Evaluated at Day 7]

   Deposits on the front surface of each lens were examined by the investigator after 7 days of lens wear, and graded on a 5-point scale; 0 = no deposit, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3 = 16%-25% deposits, and 4 = 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 Vs. grade 2 or higher.

2. Lens Front Surface Deposits at Day 14 [Evaluated at Day 14]

   Deposits on the front surface of each lens were examined by the investigator after 14 days of lens wear, and graded on a 5-point scale; 0 = 0% deposits, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3=16%-25% deposits, and 4= 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 vs. grade 2 or higher.

Secondary Outcome Measures

1. Subject Reported Overall Lens Comfort at Day 7 [Evaluated at Day 7]

   The overall lens comfort was assessed at Day 7 using the Contact Lens User Experience (CLUE) questionnaire. CLUE is 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. 97% of the scores fall within 0 and 120 (mean +/-3*SD).

2. Subject Reported Overall Lens Comfort at Day 14 [Evaluated at Day 14]

   The overall lens comfort was assessed at Day 14 using the CLUE questionnaire. CLUE is 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. 97% of the scores fall within 0 and 120 (mean +/-3*SD).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• The subject must be at least 18 years of age and no more than 39 years of age.

• The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear (DW) for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.

• The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D.

• Any cylinder power must be ≤ -0.75D.

• The subject must have visual acuity best correctable to 20/25+3 or better for each eye.

• The subject must read and sign the Statement of Informed Consent.

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

Exclusion Criteria:

• Ocular or systemic allergies or disease which might interfere with contact lens wear.

• Systemic disease or use of medication which might interfere with contact lens wear.

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

• Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which 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.

• Diabetes.

• Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).

• Habitual contact lens type is toric, multifocal, or is worn as extended wear.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Cupertino	California	United States
2		Huntington Beach	California	United States
3		Los Angeles	California	United States
4		Pismo Beach	California	United States
5		Jacksonville	Florida	United States
6		Orlando	Florida	United States
7		East Lansing	Michigan	United States
8		Columbus	Ohio	United States
9		Amarillo	Texas	United States

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: NCT01094730
• Other Study ID Numbers: CR-1636AY
• First Posted: Mar 29, 2010
• Last Update Posted: Jun 19, 2018
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Pre-assignment Detail	There were five subjects enrolled who were not randomized to a study arm due to exclusion criteria dropping the study enrollment from 185 to 180.

Arm/Group Title	Galyfilcon A Prototype/Marketed Galyfilcon A	Marketed Galyfilcon A/Galyfilcon A Prototype
Arm/Group Description	The galyfilcon A prototype lens worn daily for 12-16 days during the first period then marketed galyfilcon A lens worn daily for 12-16 days during the second period.	The marketed galyfilcon A lens worn daily for 12-16 days during the first period then the galyfilcon A prototype lens worn daily for 12-16 days during the second period.
Period Title: Period 1 (14 Days)
STARTED	92	88
COMPLETED	90	86
NOT COMPLETED	2	2
Period Title: Period 1 (14 Days)
STARTED	90	86
COMPLETED	87	84
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	All Subjects
Arm/Group Description	All enrolled subjects who have the demographic data and worn at least one study lens.
Overall Participants	183
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.5 (5.78)
Sex: Female, Male (Count of Participants)
Female	128 69.9%
Male	55 30.1%
Region of Enrollment (participants) [Number]
United States	183 100%

Outcome Measures

1. Primary Outcome

Title	Lens Front Surface Deposits at Day 7
Description	Deposits on the front surface of each lens were examined by the investigator after 7 days of lens wear, and graded on a 5-point scale; 0 = no deposit, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3 = 16%-25% deposits, and 4 = 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 Vs. grade 2 or higher.
Time Frame	Evaluated at Day 7

Outcome Measure Data

Analysis Population Description

Analysis was conducted on subjects who successfully completed the study.

Arm/Group Title	Galyfilcon A Prototype Lens	Marketed Galyfilcon A Lens
Arm/Group Description	Experimental silicone hydrogel contact lens.	Marketed silicone hydrogel contact lens.
Measure Participants	171	169
Measure eyes	341	338
Mean (Standard Deviation) [dichotomized grading scale]	1.53 (0.769)	1.53 (0.715)

2. Secondary Outcome

Title	Subject Reported Overall Lens Comfort at Day 7
Description	The overall lens comfort was assessed at Day 7 using the Contact Lens User Experience (CLUE) questionnaire. CLUE is 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. 97% of the scores fall within 0 and 120 (mean +/-3*SD).
Time Frame	Evaluated at Day 7

Outcome Measure Data

Analysis Population Description

Analysis was conducted on subjects who successfully completed the study.

Arm/Group Title	Galyfilcon A Prototype Lens	Marketed Galyfilcon A Lens
Arm/Group Description	Experimental silicon hydrogel contact lens.	Marketed silicon hydrogel contact lens.
Measure Participants	170	170
Mean (Standard Error) [CLUE points]	60.7787 (2.3993)	59.3206 (2.3850)

3. Primary Outcome

Title	Lens Front Surface Deposits at Day 14
Description	Deposits on the front surface of each lens were examined by the investigator after 14 days of lens wear, and graded on a 5-point scale; 0 = 0% deposits, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3=16%-25% deposits, and 4= 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 vs. grade 2 or higher.
Time Frame	Evaluated at Day 14

Outcome Measure Data

Analysis Population Description

Analysis was conducted on subjects who successfully completed the study.

Arm/Group Title	Galyfilcon A Prototype Lens	Marketed Galyfilcon A Lens
Arm/Group Description	Experimental silicon hydrogel contact lens.	Marketed silicon hydrogel contact lens.
Measure Participants	169	170
Measure Contact Lenses	338	340
Mean (Standard Deviation) [dichtomized grading scale]	1.61 (0.681)	1.67 (0.759)

4. Secondary Outcome

Title	Subject Reported Overall Lens Comfort at Day 14
Description	The overall lens comfort was assessed at Day 14 using the CLUE questionnaire. CLUE is 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. 97% of the scores fall within 0 and 120 (mean +/-3*SD).
Time Frame	Evaluated at Day 14

Outcome Measure Data

Analysis Population Description

Analysis was conducted on subjects who successfully completed the study.

Arm/Group Title	Galyfilcon A Prototype Lens	Marketed Galyfilcon A Lens
Arm/Group Description	Experimental silicon hydrogel contact lens.	Marketed silicon hydrogel contact lens.
Measure Participants	169	169
Mean (Standard Error) [CLUE points]	57.3230 (2.4790)	55.4675 (2.4694)

Adverse Events

Time Frame	Adverse events were recorded when the subjects were exposed to the Investigational lenses.
Arm/Group Title	All Subjects
Arm/Group Description	All subjects were to wear both lenses during the course of the study.
All Cause Mortality
	All Subjects
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Subjects
	Affected / at Risk (%)	# Events
Total	0/181 (0%)
Other (Not Including Serious) Adverse Events
	All Subjects
	Affected / at Risk (%)	# Events
Total	0/181 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Publication requires the agreement and written authorization of the Sponsor.