A Comparison of Two Daily Disposable Contact Lenses

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00634101
• Collaborator: Visioncare Research Ltd. (Other)
• Enrollment: 129
• Locations: 20
• Arms: 2
• Actual Duration (Months): 2
• Patients Per Site: 6.5
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Refractive Error; Myopia	Device: nelfilcon A; Device: narafilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 129 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Comparative Clinical Performance of Narafilcon A and the FOCUS DAILIES AquaComfort Plus Lens
• Actual Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: nefilcon A Subjects randomized to this arm received the nelfilcon A lens throughout the entire duration of the study.	Device: nelfilcon A; contact lens; Other Names: FOCUS DAILIES AquaComfort Plus
Experimental: narafilcon A Subjects randomized to this arm received the narafilcon A lens throughout the entire duration of the study.	Device: narafilcon A; contact lens; Other Names: Experimental Contact Lens

Outcome Measures

Primary Outcome Measures

1. Comfort at the End of the Day [1-Week Follow-up]

   Comfort at the end of the day was assessed by the individual questionnaire item "Comfort at the end of the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. EOD Comfort was also assessed by the individual item "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" with the respopnse categories of 1=Extremely Uncomfortable, 2=Very Uncomfortable, 3=Slightly Uncomfortable, 4=Comfortable and 5= Very Comfortable. The number of participants that responsed in each cateogry for each item was reported.

2. Limbal Hyperaemia [1-Week Follow-up]

   Limbal Hyperaemia was measured using Efron Grading Scale ranges from 0 to 4 with 0.5 units increments (0 = Normal, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe).

3. Comfort Immediately When You First Put Them on [1-Week Follow-up]

   Comfort immediately when you first put them on was assessed by the individual questionnaire item "Comfort immediately when you first put them on" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.

4. Comfort Throughout the Day [1-Week Follow-up]

   Comfort throughout the day was assessed by the individual questionnaire item "Comfort throughout the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.

5. Lack of Dryness at the End of the Day [1-Week Follow-up]

   Lack of dryness at the end of the day was assessed by the individual questionnaire item "Not making your eyes feel dry even at the end of the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.

6. Overall Opinion [1-Week Follow-up]

   Overall opinion was assessed by the individual questionnaire item "Considering your experience with the contact lenses you were provided, which statement best describes your overall opinion of these contact lenses? " with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.

7. Overall Comfort [1-Week Follow-up]

   Overall comfort was assessed by the individual questionnaire item "Overall Comfort" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.

8. My Lenses Stayed Moist [1-Week Follow-up]

   My Lenses Stayed Moist was assessed by the individual questionnaire item "They stayed moist and smooth, even after long hours at the computer" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.

9. I Forgot i Was Wearing Lenses Was [1-Week Follow-up]

   I forgot i was wearing lenses was assessed by the individual questionnaire item "They made me forget that I was wearing contact lenses" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.

10. Mainted Natural Moisture [1-Week Follow-up]

    Mainted natural moisture was assessed by the individual questionnaire item "They maintained my eyes' own natural moisture" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.

11. Comfort While Wearing Lenses in Heat/Air Conditioned Environments [1-Week Follow-up]

    Comfort while wearing lenses in heat/air conditioned environments was assessed by the individual questionnaire item "How often are you comfortable while sitting under or near an air conditioning vent or heating vent " with the response cateogries 0=Not Applicable, 1=Always, 2=Frequently, 3=Occasionally, 4=Rarely and 5=never. The number of participants that responsed in each cateogry was reported.

12. Dryness at the End of the Day [1-Week Follow-up]

    Dryness at the end of the day was assessed by the individual questionnaire item "How dry did your eyes feel at the end of the day when wearing the contact lenses you were provided" with the response cateogries 1=Extremely Dry, 2=Very Dry, 3=Moderately Dry, 4=Slightly Dry and 5=Not Dry at All. The number of participants that responsed in each cateogry was reported.

Secondary Outcome Measures

1. Overall Handling [1-Week Follow-up]

   Handling was assessed through opinion of handling in the final questionnaire. There were 5 categories Excellent (5), Very Good (4), Good (3), Fair (2) and Poor (1).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• 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	Simon Donne Opticians	Bedford	Bedfordshire	United Kingdom	MK40 1NS
2	Brock & Houlford	Brislington	Bristol	United Kingdom	BS4 3LJ
3	Keith Tempany Opticians	Broadstone	Dorset	United Kingdom	BH18 8DH
4	Cole Martin Tregaskis Optometrists	Brentwood	Essex	United Kingdom	CM15 8AG
5	Specsavers Opticians	Colchester	Essex	United Kingdom	CO1 1LJ
6	Eyecare	Ilford	Essex	United Kingdom	IG1 4DU
7	Cameron-Davies Optometrists	Southsea	Hants	United Kingdom	PO5 2AT
8	Leightons Opticians	St. Albans	Herts	United Kingdom	AL1 3LH
9	Hazel Smith Opticians	Shanklin	Isle Of Wight	United Kingdom	PO37 6JZ
10	David Gould Opticians	Rawtenstall	Lancashire	United Kingdom	BB4 7QN
11	Vision Express Optical Lab	Hendon	London	United Kingdom	NW4 3FB
12	City Opticians	Holborn	London	United Kingdom	WC2A 1AA
13	David H. Burns, BSC, FCOptom	Tottenham	London	United Kingdom	N17 0EY
14	First Contact Opticians	Pinner	Middlesex	United Kingdom	HA5 1RJ
15	S.H. Harrold	Uxbridge	Middlesex	United Kingdom	UB81JX
16	Dipple & Conway Opticians	Norwich	Norfolk	United Kingdom	NR2 1PB
17	Tompkins Knight & Son	Northampton	Northamptonhsire	United Kingdom	NN2 7BL
18	Chalmers & Sons (Opticians)	Cardiff	South Glamorgan	United Kingdom	CF24 3RQ
19	Boots Opticians Ltd	Birmingham	West Midlands	United Kingdom	B4 7TB
20	Viewpoint	York		United Kingdom	YO1 8BA

Sponsors and Collaborators

• Johnson & Johnson Vision Care, 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: NCT00634101
• Other Study ID Numbers: CR-0716; DISP-519
• First Posted: Mar 12, 2008
• Last Update Posted: Jan 6, 2021
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	A total of 129 subject were enrolled into this study. Of those enrolled, all were assigned to a study lens, however, only 125 eligble to be dispensed. Of those dispensed, 117 subjects completed the study. However, this study was utlimately terminated.

Arm/Group Title	Test (Narafilcon A)	Control (Nelfilcon A)
Arm/Group Description	Subjects randomized to receive the Test lens throughout the study	Subjects randomized to receive the Control lens throughout the study
Period Title: Overall Study
STARTED	66	59
COMPLETED	61	56
NOT COMPLETED	5	3

Baseline Characteristics

Arm/Group Title	Test (Narafilcon A)	Control (Nelfilcon A)	Total
Arm/Group Description	Subjects randomized to receive the Test lens throughout the study	Subjects randomized to receive the Control lens throughout the study	Total of all reporting groups
Overall Participants	67	62	129
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	34.5 (10.4)	33.9 (9.8)	34.2 (10.1)
Sex: Female, Male (Count of Participants)
Female	41 61.2%	48 77.4%	89 69%
Male	26 38.8%	14 22.6%	40 31%
Region of Enrollment (Count of Participants)
United Kingdom	67 100%	62 100%	129 100%

Outcome Measures

1. Primary Outcome

Title	Comfort at the End of the Day
Description	Comfort at the end of the day was assessed by the individual questionnaire item "Comfort at the end of the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. EOD Comfort was also assessed by the individual item "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" with the respopnse categories of 1=Extremely Uncomfortable, 2=Very Uncomfortable, 3=Slightly Uncomfortable, 4=Comfortable and 5= Very Comfortable. The number of participants that responsed in each cateogry for each item was reported.
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

All available data at the 1-Week follow-up.

Arm/Group Title	Test (Narafilcon A)	Control (Nelfilcon A)
Arm/Group Description	Subject that wore the Test lens throughout the study.	Subject that wore the Control lens throughout the study.
Measure Participants	53	49
5	8 11.9%	7 11.3%
4	17 25.4%	12 19.4%
3	10 14.9%	15 24.2%
2	5 7.5%	8 12.9%
1	13 19.4%	7 11.3%
Intentionally Left Blank	0 0%	0 0%
5	14 20.9%	7 11.3%
4	13 19.4%	16 25.8%
3	14 20.9%	18 29%
2	6 9%	4 6.5%
1	6 9%	3 4.8%
Intentionally Left Blank	0 0%	1 1.6%

2. Primary Outcome

Title	Limbal Hyperaemia
Description	Limbal Hyperaemia was measured using Efron Grading Scale ranges from 0 to 4 with 0.5 units increments (0 = Normal, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe).
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

All available data at the 1-Week follow-up.

Arm/Group Title	Test (Narafilcon A)	Control (Nelfilcon A)
Arm/Group Description	Subject that wore the Test lens throughout the study.	Subject that wore the Control lens throughout the study.
Measure Participants	61	56
Measure eyes	122	112
Grade 0	72	54
Grade 0.5	26	34
Grade 1	15	8
Grade 1.5	0	8
Grade 2	4	5
Grade 2.5	4	3
Grade 3	1	0
Grade 3.5	0	0
Grade 4	0	0

3. Secondary Outcome

Title	Overall Handling
Description	Handling was assessed through opinion of handling in the final questionnaire. There were 5 categories Excellent (5), Very Good (4), Good (3), Fair (2) and Poor (1).
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

All available data at the 1-Week follow-up.

Arm/Group Title	Test (Narafilcon A)	Control (Nelfilcon A)
Arm/Group Description	Subject that wore the Test lens throughout the study.	Subject that wore the Control lens throughout the study.
Measure Participants	61	56
Excellent (5)	23 34.3%	8 12.9%
Very Good (4)	27 40.3%	23 37.1%
Good (3)	8 11.9%	18 29%
Fair (2)	3 4.5%	6 9.7%
Poor (1)	0 0%	1 1.6%

4. Primary Outcome

Title	Comfort Immediately When You First Put Them on
Description	Comfort immediately when you first put them on was assessed by the individual questionnaire item "Comfort immediately when you first put them on" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

All available data at the 1-Week follow-up.

Arm/Group Title	Test (Narafilcon A)	Control (Nelfilcon A)
Arm/Group Description	Subject that wore the Test lens throughout the study.	Subject that wore the Control lens throughout the study.
Measure Participants	53	49
Excellent (5)	13 19.4%	19 30.6%
Very Good (4)	22 32.8%	13 21%
Good (3)	8 11.9%	8 12.9%
Fair (2)	6 9%	7 11.3%
Poor (1)	4 6%	2 3.2%

5. Primary Outcome

Title	Comfort Throughout the Day
Description	Comfort throughout the day was assessed by the individual questionnaire item "Comfort throughout the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

All available data at the 1-Week follow-up.

Arm/Group Title	Test (Narafilcon A)	Control (Nelfilcon A)
Arm/Group Description	Subject that wore the Test lens throughout the study.	Subject that wore the Control lens throughout the study.
Measure Participants	53	49
Excellent (5)	13 19.4%	19 30.6%
Very Good (4)	22 32.8%	13 21%
Good (3)	8 11.9%	8 12.9%
Fair (2)	6 9%	7 11.3%
Poor (1)	4 6%	2 3.2%

6. Primary Outcome

Title	Lack of Dryness at the End of the Day
Description	Lack of dryness at the end of the day was assessed by the individual questionnaire item "Not making your eyes feel dry even at the end of the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

All available data at the 1-Week follow-up.

Arm/Group Title	Test (Narafilcon A)	Control (Nelfilcon A)
Arm/Group Description	Subject that wore the Test lens throughout the study.	Subject that wore the Control lens throughout the study.
Measure Participants	53	49
Excellent (5)	12 17.9%	9 14.5%
Very Good (4)	11 16.4%	12 19.4%
Good (3)	9 13.4%	8 12.9%
Fair (2)	8 11.9%	9 14.5%
Poor (1)	13 19.4%	9 14.5%
Intentionally left Blank	0 0%	2 3.2%

7. Primary Outcome

Title	Overall Opinion
Description	Overall opinion was assessed by the individual questionnaire item "Considering your experience with the contact lenses you were provided, which statement best describes your overall opinion of these contact lenses? " with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

All available data at the 1-Week follow-up.

Arm/Group Title	Test (Narafilcon A)	Control (Nelfilcon A)
Arm/Group Description	Subject that wore the Test lens throughout the study.	Subject that wore the Control lens throughout the study.
Measure Participants	53	49
Excellent (5)	12 17.9%	12 19.4%
Very Good (4)	17 25.4%	19 30.6%
Good (3)	10 14.9%	9 14.5%
Fair (2)	9 13.4%	8 12.9%
Poor (1)	5 7.5%	1 1.6%

8. Primary Outcome

Title	Overall Comfort
Description	Overall comfort was assessed by the individual questionnaire item "Overall Comfort" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

All available data at the 1-Week follow-up.

Arm/Group Title	Test (Narafilcon A)	Control (Nelfilcon A)
Arm/Group Description	Subject that wore the Test lens throughout the study.	Subject that wore the Control lens throughout the study.
Measure Participants	53	49
Excellent (5)	12 17.9%	14 22.6%
Very Good (4)	20 29.9%	17 27.4%
Good (3)	8 11.9%	8 12.9%
Fair (2)	6 9%	7 11.3%
Poor (1)	7 10.4%	3 4.8%

9. Primary Outcome

Title	My Lenses Stayed Moist
Description	My Lenses Stayed Moist was assessed by the individual questionnaire item "They stayed moist and smooth, even after long hours at the computer" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

All available data at the 1-Week follow-up.

Arm/Group Title	Test (Narafilcon A)	Control (Nelfilcon A)
Arm/Group Description	Subject that wore the Test lens throughout the study.	Subject that wore the Control lens throughout the study.
Measure Participants	53	49
Agree Strongly (5)	8 11.9%	11 17.7%
Agree Somewhat (4)	18 26.9%	11 17.7%
Neither Agree Nor Disagree (3)	8 11.9%	10 16.1%
Disagree Somewhat (2)	8 11.9%	8 12.9%
Disagree Strongly (1)	11 16.4%	9 14.5%

10. Primary Outcome

Title	I Forgot i Was Wearing Lenses Was
Description	I forgot i was wearing lenses was assessed by the individual questionnaire item "They made me forget that I was wearing contact lenses" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

All available data at the 1-Week follow-up.

Arm/Group Title	Test (Narafilcon A)	Control (Nelfilcon A)
Arm/Group Description	Subject that wore the Test lens throughout the study.	Subject that wore the Control lens throughout the study.
Measure Participants	53	49
Agree Strongly (5)	12 17.9%	16 25.8%
Agree Somewhat (4)	16 23.9%	15 24.2%
Neither Agree Nor Disagree (3)	6 9%	4 6.5%
Disagree Somewhat (2)	13 19.4%	8 12.9%
Disagree Strongly (1)	6 9%	6 9.7%

11. Primary Outcome

Title	Mainted Natural Moisture
Description	Mainted natural moisture was assessed by the individual questionnaire item "They maintained my eyes' own natural moisture" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

All available data at the 1-Week follow-up.

Arm/Group Title	Test (Narafilcon A)	Control (Nelfilcon A)
Arm/Group Description	Subject that wore the Test lens throughout the study.	Subject that wore the Control lens throughout the study.
Measure Participants	53	49
Agree Strongly (5)	14 20.9%	10 16.1%
Agree Somewhat (4)	17 25.4%	16 25.8%
Neither Agree Nor Disagree (3)	7 10.4%	10 16.1%
Disagree Somewhat (2)	10 14.9%	6 9.7%
Disagree Strongly (1)	5 7.5%	7 11.3%

12. Primary Outcome

Title	Comfort While Wearing Lenses in Heat/Air Conditioned Environments
Description	Comfort while wearing lenses in heat/air conditioned environments was assessed by the individual questionnaire item "How often are you comfortable while sitting under or near an air conditioning vent or heating vent " with the response cateogries 0=Not Applicable, 1=Always, 2=Frequently, 3=Occasionally, 4=Rarely and 5=never. The number of participants that responsed in each cateogry was reported.
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

All available data at the 1-Week follow-up.

Arm/Group Title	Test (Narafilcon A)	Control (Nelfilcon A)
Arm/Group Description	Subject that wore the Test lens throughout the study.	Subject that wore the Control lens throughout the study.
Measure Participants	53	49
Not Applicable (0)	7 10.4%	8 12.9%
Always (1)	15 22.4%	11 17.7%
Frequently (2)	16 23.9%	12 19.4%
Occasionally (3)	10 14.9%	10 16.1%
Rarely (4)	4 6%	6 9.7%
Never (5)	1 1.5%	2 3.2%

13. Primary Outcome

Title	Dryness at the End of the Day
Description	Dryness at the end of the day was assessed by the individual questionnaire item "How dry did your eyes feel at the end of the day when wearing the contact lenses you were provided" with the response cateogries 1=Extremely Dry, 2=Very Dry, 3=Moderately Dry, 4=Slightly Dry and 5=Not Dry at All. The number of participants that responsed in each cateogry was reported.
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

All available data at the 1-Week follow-up.

Arm/Group Title	Test (Narafilcon A)	Control (Nelfilcon A)
Arm/Group Description	Subject that wore the Test lens throughout the study.	Subject that wore the Control lens throughout the study.
Measure Participants	53	49
Not Dry at all (5)	22 32.8%	11 17.7%
Slightly Dry (4)	19 28.4%	18 29%
Moderately Dry (3)	2 3%	11 17.7%
Very Dry (2)	6 9%	6 9.7%
Extremely Dry(1)	4 6%	2 3.2%
Intentionally Left Blank	0 0%	1 1.6%

Adverse Events

Time Frame	Throughout the duration of this study. Approximately 1 week per subject.
Arm/Group Title	Test (Narafilcon A)		Control (Nelfilcon A)
Arm/Group Description	Subject that were dispensed the Test lens throughout the study.		Subject that were dispensed the Control lens throughout the study.
All Cause Mortality
	Test (Narafilcon A)		Control (Nelfilcon A)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/59 (0%)
Serious Adverse Events
	Test (Narafilcon A)		Control (Nelfilcon A)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/59 (0%)
Other (Not Including Serious) Adverse Events
	Test (Narafilcon A)		Control (Nelfilcon A)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/59 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.