Clinical Performance Comparison of Two Contact Lenses | NCT00975585

Obsolete or Duplicate NCT IDs

Not provided

ID	Type	Description	Link
PHNX-518

Status Module

Sponsor/Collaborators Module

Name	Class
Visioncare Research Ltd.	OTHER

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
senofilcon A both eyes	Active Comparator	soft contact lens worn daily for 2 weeks, with a 2-week replacement regimen.	Device: senofilcon A
lotrafilcon B both eyes	Active Comparator	soft contact lens worn daily for 4 weeks, with a 4-week replacement regimen	Device: lotrafilcon B

Name	Type	Description	Arm Group Labels	Other Names
senofilcon A	Device	soft contact lens, 2-week replacement indicated	senofilcon A both eyes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average Corneal Staining	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 weeks
Visual Acuity	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.	2 weeks
Overall Comfort	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.	2 weeks
Overall Comfort	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.	2 weeks and 4 weeks

Secondary Outcomes

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

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Sheila, B Hickson-Curran, BSc, MCOptom	Johnson & Johnson Vision Care, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		North Little Rock	Arkansas	72116	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Senofilcon A	contact lens
FG001	Lotrafilcon B	contact lens

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00029.7± 7.0 BG00129.3± 6.9 BG00229.5± 6.9

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000125 BG001136 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000184 BG001195 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Average Corneal Staining

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.

Analysis included all subjects that completed the study.

Posted

Least Squares Mean

Standard Error

units on a scale

2 weeks

ID	Title	Description
OG000	Senofilcon A	contact lens
OG001	Lotrafilcon B	contact lens

Units	Counts
Participants	OG000177 OG001183

Title

Denominators

Categories

Title	Measurements
	OG0000.157± 0.018 OG0010.170± 0.018

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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.	Mixed Models Analysis				Mean Difference (Final Values)	-0.014	Standard Error of the Mean	0.020	2-Sided	97.46	-0.058	0.031			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.		Non-Inferiority or Equivalence

Primary

Visual Acuity

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.

Posted

Least Squares Mean

Standard Error

logMAR units

2 weeks

ID	Title	Description
OG000	Senofilcon A	contact lens
OG001	Lotrafilcon B	contact lens

Units	Counts
Participants	OG000

Primary

Overall Comfort

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.

Analysis includes subjects that completed the study.

Posted

Least Squares Mean

Standard Error

units on a scale

2 weeks

ID	Title	Description
OG000	Senofilcon A	contact lens
OG001	Lotrafilcon B	contact lens

Units	Counts
Participants	OG000

Primary

Overall Comfort

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.

Analysis includes all subjects that completed the study.

Posted

Least Squares Mean

Standard Error

units on a scale

2 weeks and 4 weeks

ID	Title	Description
OG000	Lotrafilcon B at 2 Weeks	lotrafilcon B contact lens after two weeks of wear
OG001	Lotrafilcon B at 4 Weeks	lotrafilcon B contact lens after four weeks of wear

Units	Counts
Participants	OG000

Secondary

Limbal Redness

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

Analysis includes subjects that completed the study.

Posted

Least Squares Mean

Standard Error

units on a scale

2 weeks

ID	Title	Description
OG000	Senofilcon A	contact lens
OG001	Lotrafilcon B	contact lens

Units	Counts
Participants	OG000

Secondary

Bulbar Redness

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

Analysis includes subjects that completed the study.

Posted

Least Squares Mean

Standard Error

units on a scale

2 weeks

ID	Title	Description
OG000	Senofilcon A	contact lens
OG001	Lotrafilcon B	contact lens

Units	Counts
Participants	OG000

Secondary

Symptoms of Dryness

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

Analysis includes subjects that completed the study.

Posted

Least Squares Mean

Standard Error

units on a scale

2 weeks

ID	Title	Description
OG000	Senofilcon A	contact lens
OG001	Lotrafilcon B	contact lens

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Senofilcon A	contact lens			0	184	0	184
EG001	Lotrafilcon B	contact lens			0	195	0	195

ID	Term
D009216	Myopia

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

ID	Title	Description
BG000	Senofilcon A	contact lens
BG001	Lotrafilcon B	contact lens
BG002	Total	Total of all reporting groups