The Clinical Evaluation of Two Daily Disposable Contact Lenses

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00762996
• Collaborator: Eurolens Research (Industry)
• Enrollment: 65
• Location: 1
• Arms: 4
• Duration (Months): 2
• Patients Per Site Per Month: 32.4

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: etafilcon A; Device: omafilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 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: etafilcon A/etafilcon A Period 1: etafilcon A, Period 2: etafilcon A	Device: etafilcon A; contact lens
Active Comparator: etafilcon A/omafilcon A Period 1: etafilcon A, Period 2: omafilcon A	Device: etafilcon A; contact lens; Device: omafilcon A; contact lens
Active Comparator: omafilcon A/etafilcon A Period 1: omafilcon A, Period 2: etafilcon A	Device: etafilcon A; contact lens; Device: omafilcon A; contact lens
Active Comparator: omafilcon A/omafilcon A Period 1: omafilcon A, Period 2: omafilcon A	Device: omafilcon A; contact lens

Outcome Measures

Primary Outcome Measures

1. Distance Visual Acuity [1 week]

   logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.

Secondary Outcome Measures

1. Lens Comfort [1 week]

   A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.>0 = comfortable, <0 = uncomfortable

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• They are of legal age (18 years) and capacity to volunteer.

• They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.

• They are willing and able to follow the protocol.

• They would be expected to attain at least 6.9 (20/30) in each eye with the study lenses.

• They are able to wear contact lenses which have a back vertex power of -1.00 to -6.00DS.

• They have a maximum of 1.00D of refractive astigmatism (i.e. < 1.00 DC).

• They have worn soft contact lenses within six months of starting the study.

Exclusion Criteria:

• They have an ocular disorder which would normally contra-indicate contact lens wear.

• They have a systemic disorder which would normally contra-indicate contact lens wear.

• They are using any topical medication such as eye drops or ointment.

• They are aphakic.

• They have had corneal refractive surgery.

• They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.

• They are pregnant or lactating.

• They have grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.

• They have any infectious disease (e.g., hepatitis) or any immunosuppressive disease (e.g., HIV).

• They have diabetes.

• They are currently taking part in any other clinical study or research.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurolens Research	Manchester		United Kingdom	M60 1QD

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.
• Eurolens Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT00762996
• Other Study ID Numbers: CR-0707
• First Posted: Sep 30, 2008
• Last Update Posted: Jun 19, 2018
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Etafilcon A / Etafilcon A	Etafilcon A / Omafilcon A	Omafilcon A / Etafilcon A	Omafilcon A / Omafilcon A
Arm/Group Description	Period 1: etafilcon A, Period 2: etafilcon A	Period 1: etafilcon A, Period 2: omafilcon A	Period 1: omafilcon A, Period 2: etafilcon A	Period 1: omafilcon A, Period 2: omafilcon A
Period Title: Period One
STARTED	15	16	17	17
COMPLETED	15	16	13	16
NOT COMPLETED	0	0	4	1
Period Title: Period One
STARTED	15	16	13	16
COMPLETED	15	16	13	16
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Entire Population
Arm/Group Description
Overall Participants	65
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.9 (5.3)
Sex: Female, Male (Count of Participants)
Female	41 63.1%
Male	24 36.9%

Outcome Measures

1. Primary Outcome

Title	Distance Visual Acuity
Description	logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Etafilcon A	Omafilcon A
Arm/Group Description
Measure Participants	44	45
Least Squares Mean (Standard Error) [logMar]	0.03460 (0.007129)	0.02931 (0.006666)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etafilcon A, Omafilcon A
	Comments	Null Hypothesis: etafilcon A is greater than or equal to omafilcon A.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	margin +/- 0.5 logMar lines The range of non-inferiority for this value is 0.50 thus +/- 0.50 is considered non-inferior to the 0.0 mark. logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.005287
	Confidence Interval	() 95%; -0.01389 to 0.2447
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.009760
	Estimation Comments	logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.

2. Secondary Outcome

Title	Lens Comfort
Description	A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.>0 = comfortable, <0 = uncomfortable
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Etafilcon A	Omafilcon A
Arm/Group Description
Measure Participants	15	16
Least Squares Mean (Standard Error) [Units on a scale]	0.3113 (0.1765)	-0.1645 (0.2075)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etafilcon A, Omafilcon A
	Comments
	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	0.4757
	Confidence Interval	() 95%; 0.05563 to 0.4757
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.2505
	Estimation Comments	Mean difference is etafilcon A minus omafilcon A.

Adverse Events

Arm/Group Title	Etafilcon A / Etafilcon A		Etafilcon A / Omafilcon A		Omafilcon A / Etafilcon A		Omafilcon A / Omafilcon A
Arm/Group Description	Period 1: etafilcon A, Period 2: etafilcon A		Period 1: etafilcon A, Period 2: omafilcon A		Period 1: omafilcon A, Period 2: etafilcon A		Period 1: omafilcon A, Period 2: omafilcon A
All Cause Mortality
	Etafilcon A / Etafilcon A		Etafilcon A / Omafilcon A		Omafilcon A / Etafilcon A		Omafilcon A / Omafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Etafilcon A / Etafilcon A		Etafilcon A / Omafilcon A		Omafilcon A / Etafilcon A		Omafilcon A / Omafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/10 (0%)		0/17 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Etafilcon A / Etafilcon A		Etafilcon A / Omafilcon A		Omafilcon A / Etafilcon A		Omafilcon A / Omafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/10 (0%)		0/17 (0%)		0/17 (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.