Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses

This study has been completed.

Sponsor:

Collaborators:

Johnson & Johnson K.K. Medical Company

Visioncare Research Ltd.

Information provided by (Responsible Party):

Vistakon

ClinicalTrials.gov Identifier:

NCT01155323

First received: June 30, 2010

Last updated: October 5, 2011

Last verified: October 2011

History of Changes

Results First Received: August 29, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Myopia
Interventions:	Device: etafilcon A Device: omafilcon A

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Etafilcon A/Omafilcon A	etafilcon A contact lenses will be worn first and omafilcon A contact lenses will be worn second.
Omafilcon A/Etafilcon A	omafilcon A contact lenses will be worn first and etafilcon A contact lenses will be worn second.

Participant Flow for 2 periods

Period 1: First Intervention

	Etafilcon A/Omafilcon A	Omafilcon A/Etafilcon A
STARTED	60	58
COMPLETED	59	57
NOT COMPLETED	1	1
exclusion criteria	1	1

Period 2: Second Intervention

	Etafilcon A/Omafilcon A	Omafilcon A/Etafilcon A
STARTED	59	57
COMPLETED	58	56
NOT COMPLETED	1	1
Lost to Follow-up	1	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Total Number of Participants	This represents all subjects that completed the study minus one additional subject excluded due the discovery after study completion that the subject conflicted with exclusion criteria.

Baseline Measures

	Total Number of Participants
Number of Participants [units: participants]	113
Age [units: years] Mean ± Standard Deviation	25.3 ± 4.4
Gender [units: participants]
Female	80
Male	33
Region of Enrollment [units: participants]
Singapore	113

Outcome Measures

Hide All Outcome Measures

1. Primary:

Subjective Rating of Comfort [ Time Frame: after 1 week of lens wear ]

Measure Type	Primary
Measure Title	Subjective Rating of Comfort
Measure Description	This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Time Frame	after 1 week of lens wear
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis population represents subjects that completed the study per protocol.

Reporting Groups

	Description
Etafilcon A	soft contact lens replaced daily, worn for one week.
Omafilcon A	soft contact lens replaced daily, worn for one week.

Measured Values

	Etafilcon A	Omafilcon A
Number of Participants Analyzed [units: participants]	113	113
Subjective Rating of Comfort [units: Units on a scale] Least Squares Mean ± Standard Error	3.33 ± 0.09	3.32 ± 0.09

Statistical Analysis 1 for Subjective Rating of Comfort

Groups ^[1]	All groups
Mean Difference (Final Values) ^[2]	0.01
Standard Error of the mean	± 0.11
95% Confidence Interval	( -0.21 to 0.23 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The alternative hypothesis was that etafilcon A would be superior to omafilcon A for comfort.
[2]	Other relevant estimation information:
	Mean difference is calculated as etafilcon A minus omafilcon A.

2. Primary:

Vision Quality [ Time Frame: after 1 week of lens wear ]

Measure Type	Primary
Measure Title	Vision Quality
Measure Description	This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Time Frame	after 1 week of lens wear
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis population represents subjects that completed the study per protocol.

Reporting Groups

	Description
Etafilcon A	soft contact lens replaced daily, worn for one week.
Omafilcon A	soft contact lens replaced daily, worn for one week.

Measured Values

	Etafilcon A	Omafilcon A
Number of Participants Analyzed [units: participants]	113	113
Vision Quality [units: Units on a scale] Least Squares Mean ± Standard Error	3.53 ± 0.08	3.50 ± 0.08

Statistical Analysis 1 for Vision Quality

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Mean Difference (Final Values) ^[3]	0.03
Standard Error of the mean	± 0.11
95% Confidence Interval	( -0.19 to 0.25 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for vision.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Non-inferiority margin = -0.50
[3]	Other relevant estimation information:
	The mean difference is calculated as etafilcon A minus omafilcon A.

3. Primary:

Subjective Rating of Handling [ Time Frame: after 1 week of lens wear ]

Measure Type	Primary
Measure Title	Subjective Rating of Handling
Measure Description	This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Time Frame	after 1 week of lens wear
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis population represents subjects that completed the study per protocol.

Reporting Groups

	Description
Etafilcon A	soft contact lens replaced daily, worn for one week.
Omafilcon A	soft contact lens replaced daily, worn for one week.

Measured Values

	Etafilcon A	Omafilcon A
Number of Participants Analyzed [units: participants]	113	113
Subjective Rating of Handling [units: Units on a scale] Least Squares Mean ± Standard Error	3.48 ± 0.09	3.48 ± 0.09

Statistical Analysis 1 for Subjective Rating of Handling

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Mean Difference (Final Values) ^[3]	0.00
Standard Error of the mean	± 0.11
95% Confidence Interval	( -0.22 to 0.22 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for lens handling.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Non-inferiority margin = -0.50
[3]	Other relevant estimation information:
	The mean difference is calculated as etafilcon A minus omafilcon A.

4. Primary:

Corneal Staining [ Time Frame: after 1 week of lens wear ]

Measure Type	Primary
Measure Title	Corneal Staining
Measure Description	Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.
Time Frame	after 1 week of lens wear
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis population represents subjects that completed the study per protocol.

Reporting Groups

	Description
Etafilcon A	soft contact lens replaced daily, worn for one week.
Omafilcon A	soft contact lens replaced daily, worn for one week.

Measured Values

	Etafilcon A	Omafilcon A
Number of Participants Analyzed [units: participants]	113	113
Corneal Staining [units: Units on a scale] Least Squares Mean ± Standard Error	0.07 ± 0.01	0.09 ± 0.01

Statistical Analysis 1 for Corneal Staining

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Mean Difference (Final Values) ^[3]	-0.01
Standard Error of the mean	± 0.01
95% Confidence Interval	( -0.03 to 0.01 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A for corneal staining.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Margin = +/-0.50
[3]	Other relevant estimation information:
	The mean difference is calculated as etafilcon A minus omafilcon A.

5. Primary:

Subjective Rating of Quality Perceptions [ Time Frame: after 1 week of lens wear ]

Measure Type	Primary
Measure Title	Subjective Rating of Quality Perceptions
Measure Description	This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Time Frame	after 1 week of lens wear
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis population represents subjects that completed the study per protocol.

Reporting Groups

	Description
Etafilcon A	soft contact lens replaced daily, worn for one week.
Omafilcon A	soft contact lens replaced daily, worn for one week.

Measured Values

	Etafilcon A	Omafilcon A
Number of Participants Analyzed [units: participants]	113	113
Subjective Rating of Quality Perceptions [units: Units on a scale] Least Squares Mean ± Standard Error	3.51 ± 0.08	3.44 ± 0.08

Statistical Analysis 1 for Subjective Rating of Quality Perceptions

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Mean Difference (Final Values) ^[3]	0.07
Standard Error of the mean	± 0.11
95% Confidence Interval	( -0.15 to 0.29 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for quality perceptions.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Non-inferiority margin = -0.50
[3]	Other relevant estimation information:
	The mean difference is calculated as etafilcon A minus omafilcon A.

6. Primary:

Limbal Hyperemia [ Time Frame: after 1 week of wear ]

Measure Type	Primary
Measure Title	Limbal Hyperemia
Measure Description	This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe.
Time Frame	after 1 week of wear
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis population represents subjects that completed the study per protocol.

Reporting Groups

	Description
Etafilcon A	soft contact lens replaced daily, worn for one week.
Omafilcon A	soft contact lens replaced daily, worn for one week.

Measured Values

	Etafilcon A	Omafilcon A
Number of Participants Analyzed [units: participants]	113	113
Limbal Hyperemia [units: Units on a scale] Least Squares Mean ± Standard Error	0.51 ± 0.02	0.48 ± 0.02

Statistical Analysis 1 for Limbal Hyperemia

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Mean Difference (Final Values) ^[3]	0.03
Standard Error of the mean	± 0.02
95% Confidence Interval	( -0.01 to 0.06 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A from limbal hyperemia.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Margin = +/- 0.50
[3]	Other relevant estimation information:
	The mean difference is calculated as etafilcon A minus omafilcon A.

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The results of the study may not be published or publicly presented without prior written approval of the sponsor. If the investigator wishes to publish or present any study findings, investigator shall contact sponsor to discuss publication plan.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Wakana Katabami
Organization: Johnson and Johnson K.K.
phone: 81-34411-8040 ext 22025
e-mail: wkatabam@its.jnj.com

No publications provided

Responsible Party:	Vistakon
ClinicalTrials.gov Identifier:	NCT01155323 History of Changes
Other Study ID Numbers:	CR-0926, DISP-523
Study First Received:	June 30, 2010
Results First Received:	August 29, 2011
Last Updated:	October 5, 2011
Health Authority:	Singapore: independent review board

To Top