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A Comparison of Two Daily Disposable Contact Lenses

Primary Purpose

Refractive Error, Myopia

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
nelfilcon A
narafilcon A
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Error

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Simon Donne Opticians
  • Brock & Houlford
  • Keith Tempany Opticians
  • Cole Martin Tregaskis Optometrists
  • Specsavers Opticians
  • Eyecare
  • Cameron-Davies Optometrists
  • Leightons Opticians
  • Hazel Smith Opticians
  • David Gould Opticians
  • Vision Express Optical Lab
  • City Opticians
  • David H. Burns, BSC, FCOptom
  • First Contact Opticians
  • S.H. Harrold
  • Dipple & Conway Opticians
  • Tompkins Knight & Son
  • Chalmers & Sons (Opticians)
  • Boots Opticians Ltd
  • Viewpoint

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

nefilcon A

narafilcon A

Arm Description

Subjects randomized to this arm received the nelfilcon A lens throughout the entire duration of the study.

Subjects randomized to this arm received the narafilcon A lens throughout the entire duration of the study.

Outcomes

Primary Outcome Measures

Comfort at the End of the Day
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.
Limbal Hyperaemia
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).
Comfort Immediately When You First Put Them on
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.
Comfort Throughout the Day
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.
Lack of Dryness at the End of the Day
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.
Overall Opinion
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.
Overall Comfort
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.
My Lenses Stayed Moist
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.
I Forgot i Was Wearing Lenses Was
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.
Mainted Natural Moisture
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.
Comfort While Wearing Lenses in Heat/Air Conditioned Environments
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.
Dryness at the End of the Day
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

Overall Handling
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).

Full Information

First Posted
February 28, 2008
Last Updated
December 9, 2020
Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Visioncare Research Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00634101
Brief Title
A Comparison of Two Daily Disposable Contact Lenses
Official Title
The Comparative Clinical Performance of Narafilcon A and the FOCUS DAILIES AquaComfort Plus Lens
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
Study was resurrected as NCT00727558 (CR-0808)
Study Start Date
January 1, 2008 (Actual)
Primary Completion Date
March 1, 2008 (Actual)
Study Completion Date
March 1, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Visioncare Research Ltd.

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error, Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nefilcon A
Arm Type
Active Comparator
Arm Description
Subjects randomized to this arm received the nelfilcon A lens throughout the entire duration of the study.
Arm Title
narafilcon A
Arm Type
Experimental
Arm Description
Subjects randomized to this arm received the narafilcon A lens throughout the entire duration of the study.
Intervention Type
Device
Intervention Name(s)
nelfilcon A
Other Intervention Name(s)
FOCUS DAILIES AquaComfort Plus
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
narafilcon A
Other Intervention Name(s)
Experimental Contact Lens
Intervention Description
contact lens
Primary Outcome Measure Information:
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
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
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
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
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
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
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
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
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
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
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
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
Secondary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 with 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 successfully worn 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 oedema, corneal vascularisation, 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 have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Facility Information:
Facility Name
Simon Donne Opticians
City
Bedford
State/Province
Bedfordshire
ZIP/Postal Code
MK40 1NS
Country
United Kingdom
Facility Name
Brock & Houlford
City
Brislington
State/Province
Bristol
ZIP/Postal Code
BS4 3LJ
Country
United Kingdom
Facility Name
Keith Tempany Opticians
City
Broadstone
State/Province
Dorset
ZIP/Postal Code
BH18 8DH
Country
United Kingdom
Facility Name
Cole Martin Tregaskis Optometrists
City
Brentwood
State/Province
Essex
ZIP/Postal Code
CM15 8AG
Country
United Kingdom
Facility Name
Specsavers Opticians
City
Colchester
State/Province
Essex
ZIP/Postal Code
CO1 1LJ
Country
United Kingdom
Facility Name
Eyecare
City
Ilford
State/Province
Essex
ZIP/Postal Code
IG1 4DU
Country
United Kingdom
Facility Name
Cameron-Davies Optometrists
City
Southsea
State/Province
Hants
ZIP/Postal Code
PO5 2AT
Country
United Kingdom
Facility Name
Leightons Opticians
City
St. Albans
State/Province
Herts
ZIP/Postal Code
AL1 3LH
Country
United Kingdom
Facility Name
Hazel Smith Opticians
City
Shanklin
State/Province
Isle Of Wight
ZIP/Postal Code
PO37 6JZ
Country
United Kingdom
Facility Name
David Gould Opticians
City
Rawtenstall
State/Province
Lancashire
ZIP/Postal Code
BB4 7QN
Country
United Kingdom
Facility Name
Vision Express Optical Lab
City
Hendon
State/Province
London
ZIP/Postal Code
NW4 3FB
Country
United Kingdom
Facility Name
City Opticians
City
Holborn
State/Province
London
ZIP/Postal Code
WC2A 1AA
Country
United Kingdom
Facility Name
David H. Burns, BSC, FCOptom
City
Tottenham
State/Province
London
ZIP/Postal Code
N17 0EY
Country
United Kingdom
Facility Name
First Contact Opticians
City
Pinner
State/Province
Middlesex
ZIP/Postal Code
HA5 1RJ
Country
United Kingdom
Facility Name
S.H. Harrold
City
Uxbridge
State/Province
Middlesex
ZIP/Postal Code
UB81JX
Country
United Kingdom
Facility Name
Dipple & Conway Opticians
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR2 1PB
Country
United Kingdom
Facility Name
Tompkins Knight & Son
City
Northampton
State/Province
Northamptonhsire
ZIP/Postal Code
NN2 7BL
Country
United Kingdom
Facility Name
Chalmers & Sons (Opticians)
City
Cardiff
State/Province
South Glamorgan
ZIP/Postal Code
CF24 3RQ
Country
United Kingdom
Facility Name
Boots Opticians Ltd
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B4 7TB
Country
United Kingdom
Facility Name
Viewpoint
City
York
ZIP/Postal Code
YO1 8BA
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Comparison of Two Daily Disposable Contact Lenses

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