A Comparison of Two Daily Disposable Contact Lenses

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00600080
• Collaborator: University of Manchester (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 20.1

Study Details

Study Description

Brief Summary

This study seeks to evaluate the clinical performance of a recently improved daily disposable contact lens to an established daily disposable contact lens that contains a wetting agent.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Comparative Clinical Performance of the Etafilcon A Lens and the DAILIES AquaComfort Plus Lens
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: etafilcon A first nelfilcon A second etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2	Device: etafilcon A; contact lens worn daily for one week (first or second week depending on arm); Other Names: 1-DAY ACUVUE MOIST ; Device: nelfilcon A; Contact lens worn daily for one week (first or second week depending on arm); Other Names: DAILIES AquaComfort Plus
Other: nelfilcon A first, etafilcon A second nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2	Device: etafilcon A; contact lens worn daily for one week (first or second week depending on arm); Other Names: 1-DAY ACUVUE MOIST ; Device: nelfilcon A; Contact lens worn daily for one week (first or second week depending on arm); Other Names: DAILIES AquaComfort Plus

Outcome Measures

Primary Outcome Measures

1. Visual Acuity [2-week]

   Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination.

2. Subjective Lens Comfort [2-week]

   Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used.

Secondary Outcome Measures

1. Subject-reported Overall Product Performance [2-week]

   Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used.

2. Optimum Lens Fit [Baseline, 1-week, 2-week]

   Number of subjects that measured as an optimum fit. Lens fit will be assessed using the following evaluations: horizontal and vertical centration, corneal coverage and movement. Normally, for an acceptable fit, centration and movement will fall within currently accepted clinical criteria [between -1 and +1 on a -2 to +2 grading scale.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

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

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

3. They are willing and able to follow the protocol.

4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.

5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.

6. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).

7. They have successfully worn contact lenses within six months of starting the study. -

Exclusion Criteria:

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

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

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

4. They are aphakic.

5. They have had corneal refractive surgery.

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

7. They are pregnant or lactating.

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

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

10. They have diabetes.

11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience	Manchester		United Kingdom	M60 1QD

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.
• University of Manchester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT00600080
• Other Study ID Numbers: CR-0729
• First Posted: Jan 24, 2008
• Last Update Posted: May 21, 2015
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	Sixty subjects were enrolled onto the study to wear contact lenses for two weeks on a daily wear basis.
Pre-assignment Detail	Sixty subjects enrolled and sixty subjects completed.

Arm/Group Title	Etafilcon A/Nelfilcon A	Nelfilcon A/Etafilcon A
Arm/Group Description	etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2.	nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2.
Period Title: Period 1: Baseline to One-week
STARTED	28	32
COMPLETED	28	32
NOT COMPLETED	0	0
Period Title: Period 1: Baseline to One-week
STARTED	28	32
COMPLETED	28	32
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Subjects
Arm/Group Description	All subjects crossed over to use each treatment for one week
Overall Participants	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.6 (8.6)
Sex: Female, Male (Count of Participants)
Female	43 71.7%
Male	17 28.3%
Region of Enrollment (participants) [Number]
United Kingdom	60 100%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity
Description	Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination.
Time Frame	2-week

Outcome Measure Data

Analysis Population Description

Subjects analyzed are those who were enrolled, randomized to a study arm, and completed the study.

Arm/Group Title	Nelfilcon A	Etafilcon A
Arm/Group Description	All subjects who wore nelfilcon A lenses for one week	All subjects who wore etafilcon A lenses for one week
Measure Participants	60	60
High Contrast	-0.10 (0.07)	-0.10 (0.07)
Low Contrast	0.17 (0.09)	0.18 (0.09)

2. Secondary Outcome

Title	Subject-reported Overall Product Performance
Description	Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used.
Time Frame	2-week

Outcome Measure Data

Analysis Population Description

Analyzed subjects were those who were enrolled and randomized to a study arm.

Arm/Group Title	Nelfilcon A	Etafilcon A
Arm/Group Description	All subjects who wore nelfilcon A lenses for one week	All subjects who wore etafilcon A lenses for one week
Measure Participants	60	60
Least Squares Mean (Standard Error) [units on a scale]	86.5 (11.3)	87.7 (12.3)

3. Secondary Outcome

Title	Optimum Lens Fit
Description	Number of subjects that measured as an optimum fit. Lens fit will be assessed using the following evaluations: horizontal and vertical centration, corneal coverage and movement. Normally, for an acceptable fit, centration and movement will fall within currently accepted clinical criteria [between -1 and +1 on a -2 to +2 grading scale.
Time Frame	Baseline, 1-week, 2-week

Outcome Measure Data

Analysis Population Description

Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.

Arm/Group Title	Nelfilcon A	Etafilcon A
Arm/Group Description	All subjects who wore nelfilcon A lenses for one week	All subjects who wore etafilcon A lenses for one week
Measure Participants	60	60
At Dispensing	22 36.7%	18 NaN
At Follow-up	18 30%	18 NaN

4. Primary Outcome

Title	Subjective Lens Comfort
Description	Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used.
Time Frame	2-week

Outcome Measure Data

Analysis Population Description

Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.

Arm/Group Title	Nelfilcon A	Etafilcon A
Arm/Group Description	All subjects who wore nelfilcon A lenses for one week	All subjects who wore etafilcon A lenses for one week
Measure Participants	60	60
Least Squares Mean (Standard Deviation) [units on a scale]	86.0 (13.9)	88.2 (12.4)

Adverse Events

Arm/Group Title	Etafilcon A First Nelfilcon A Second		Nelfilcon A First Etafilcon A Second
Arm/Group Description	etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2		nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2
All Cause Mortality
	Etafilcon A First Nelfilcon A Second		Nelfilcon A First Etafilcon A Second
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Etafilcon A First Nelfilcon A Second		Nelfilcon A First Etafilcon A Second
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Etafilcon A First Nelfilcon A Second		Nelfilcon A First Etafilcon A Second
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Publication requires agreement and written authorization from Sponsor.