Clinical Comparison of Two Silicone-Hydrogel Contact Lenses

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00762385
• Collaborator: Foresight Regulatory Strategies, Inc. (Industry), Visioncare Research Ltd. (Other)
• Enrollment: 97
• Arms: 2
• Duration (Months): 2

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the clinical performance of two silicone-hydrogel contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	Device: galyfilcon A; Device: comfilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 97 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: galyfilcon A/comfilcon A galyfilcon A first, comfilcon A second	Device: galyfilcon A; galyfilcon A; Device: comfilcon A; comfilcon A
Active Comparator: comfilcon A/galyfilcon A comfilcon A first, galyfilcon A second	Device: galyfilcon A; galyfilcon A; Device: comfilcon A; comfilcon A

Outcome Measures

Primary Outcome Measures

1. Lens Comfort [1-week, 2- weeks]

   >0 = comfortable, <0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes.

2. Comfort Symptoms [1-week, 2-weeks]

   A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. >0 = comfortable, <0 = uncomfortable

Secondary Outcome Measures

1. Overall Corneal Staining [2 weeks]

   Measured for 5 zones of the cornea (superior, nasal, central, inferior, temporal)on a 0 to 3 grade scale (NEI 0-3 scale). Grade 0 = Normal/ grade 1 = mild, superficial stippling/ grade 2 = moderate, punctate staining including superficial abrasion of the cornea/ grade 3 = severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.

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 and less than or equal to 39 years of age and have a need for vision correction in both eyes.

• The subject must require a lens power between -1.00 to -6.00D and have no more than 1.00D of corneal cylinder.

• The subject, based on his/her knowledge, must be in good general health.

• The subject must be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluations.

• Subject must be a current adapted daily wearer of soft contact lenses with at least 6 months of CL wear.

• Subject must agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.

• Subject must be willing and able to use only the care systems and lubricating drops provided for the study during the 4 week period.

• The subject must read, indicate understanding of and sign the Informed Consent Form.

Exclusion Criteria:

• The subject is a rigid gas permeable (RGP) or daily disposable lens wearer.

• The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids or associated structures.

• The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjogren's syndrome, type II diabetes, etc.)

• Slit lamp findings that would contraindicate contact lens wear such as:

• pathological dry eye or associated findings

• pterygium or corneal scars within the visual axis

• neovascularization equal to or greater than 1mm in from the limbus

• history of giant papillary conjunctivitis (GPC) worse than grade 2

• anterior uveitis or iritis (past or present)

• seborrhoeic eczema

• seborrhoeic conjunctivitis

• A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.

• A known history of corneal hypoesthesia (reduced corneal sensitivity).

• Contact lens snellen visual acuities (VA) worse than 20/30.

• Aphakia, keratoconus or a highly irregular cornea.

• Current pregnancy or lactation (to the best of the subject's knowledge)

• Any active participation in another clinical study at any time during this study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.
• Foresight Regulatory Strategies, Inc.
• Visioncare Research Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT00762385
• Other Study ID Numbers: CR-0713
• First Posted: Sep 30, 2008
• Last Update Posted: Jun 19, 2018
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Arm/Group Title	Galyfilcon A / Comfilcon A	Comfilcon A / Galyfilcon A
Arm/Group Description	galyfilcon A contact lenses first period, comfilcon a contact lenses second period	comfilcon A contact lenses first period, galyfilcon A contact lenses second period
Period Title: First Intervention
STARTED	51	46
COMPLETED	49	42
NOT COMPLETED	2	4
Period Title: First Intervention
STARTED	49	42
COMPLETED	46	39
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Completed Population
Arm/Group Description	Includes subjects randomized to galyfilcon A/comfilcon A and comfilcon A/galyfilcon A and that completed the study.
Overall Participants	85
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.2 (6.7)
Sex: Female, Male (Count of Participants)
Female	64 75.3%
Male	21 24.7%

Outcome Measures

1. Primary Outcome

Title	Lens Comfort
Description	>0 = comfortable, <0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes.
Time Frame	1-week, 2- weeks

Outcome Measure Data

Analysis Population Description

Only participants who completed the study per protocol (n=78)

Arm/Group Title	Galyfilcon A	Comfilcon A
Arm/Group Description	galyfilcon A administered in either the first intervention period or the second intervention period.	comfilcon A administered in either the first intervention period or second intervention period.
Measure Participants	78	78
Least Squares Mean (Standard Error) [combined score]	0.1452 (0.1097)	0.1135 (0.1112)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Galyfilcon A, Comfilcon A
	Comments	Results is overall lens effect with time as a covariate.
	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	0.03164
	Confidence Interval	() 98.3%; -0.2346 to 0.03164
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.1247
	Estimation Comments	Mean difference is galyfilcon A minus comfilcon A.

2. Secondary Outcome

Title	Overall Corneal Staining
Description	Measured for 5 zones of the cornea (superior, nasal, central, inferior, temporal)on a 0 to 3 grade scale (NEI 0-3 scale). Grade 0 = Normal/ grade 1 = mild, superficial stippling/ grade 2 = moderate, punctate staining including superficial abrasion of the cornea/ grade 3 = severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Only the participants who completed the study per protocol (n=78)

Arm/Group Title	Galyfilcon A	Comfilcon A
Arm/Group Description
Measure Participants	78	78
Least Squares Mean (Standard Error) [combined score]	0.07582 (0.02192)	0.07026 (0.02192)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Galyfilcon A, Comfilcon A
	Comments	Results is overall lens effect with time as a covariate.
	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	0.005560
	Confidence Interval	() 98.3%; -0.04297 to 0.005560
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.02287
	Estimation Comments	Mean difference is galyfilcon A minus comfilcon A.

3. Primary Outcome

Title	Comfort Symptoms
Description	A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. >0 = comfortable, <0 = uncomfortable
Time Frame	1-week, 2-weeks

Outcome Measure Data

Analysis Population Description

Only participants who completed the study per protocol (n=78)

Arm/Group Title	Galyfilcon A	Comfilcon A
Arm/Group Description	galyfilcon A administered in either the first intervention period or the second intervention period.	comfilcon A administered in either the first intervention period or the second intervention period.
Measure Participants	78	78
Least Squares Mean (Standard Error) [score]	0.2440 (0.1262)	-0.02862 (0.1275)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Galyfilcon A, Comfilcon A
	Comments	Results is overall lens effect with time as a covariate.
	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	0.2726
	Confidence Interval	() 98.3%; 0.04553 to 0.2726
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.1064
	Estimation Comments	Mean difference is galyfilcon A minus comfilcon A.

Adverse Events

Arm/Group Title	Galyfilcon A / Comfilcon A		Comfilcon A / Galyfilcon A
Arm/Group Description	galyfilcon A contact lenses first period, comfilcon a contact lenses second period		comfilcon A contact lenses first period, galyfilcon A contact lenses second period
All Cause Mortality
	Galyfilcon A / Comfilcon A		Comfilcon A / Galyfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Galyfilcon A / Comfilcon A		Comfilcon A / Galyfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/46 (0%)
Other (Not Including Serious) Adverse Events
	Galyfilcon A / Comfilcon A		Comfilcon A / Galyfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/46 (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.