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A Comparison of Daily Disposable Contact Lenses.

Primary Purpose

Myopia

Status
Completed
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 Myopia focused on measuring refractive error

Eligibility Criteria

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

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.

Sites / Locations

  • Simon Donne Opticians 3-4
  • Brock & Houlford
  • The Contact Lens Centre
  • Keith Tempany Opticians
  • Eyecare
  • Leightons Opticians
  • Hazel Smith Opticians
  • Bowden & Lowe
  • David Gould Opticians
  • Vision Express Optical Lab
  • David H Burns BSC, FCOptom
  • First Contact Opticians
  • Chalmers & Son (Opticians)
  • Susan R Bowers Opticians
  • Ellis & Killpartrick
  • Hawkes & Wainer
  • City Opticians
  • Tompkins Knight & Son
  • Viewpoint

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

narafilcon A

nelfilcon A

Arm Description

spherical soft contact lens worn as a daily disposable modality for one week

spherical soft contact lens worn as a daily disposable modality for one week

Outcomes

Primary Outcome Measures

Overall Comfort
Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent
Measured Limbal Hyperemia
Measurement of redness of the limbus, graded using half-grade increments using the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.

Secondary Outcome Measures

Overall Handling
Rating of overall ease of handling using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.
How Comfortable Eyes Feel at the End of the Day
Rating of "How comfortable did your eyes feel at the end of the day when wearing the contact lenses provided" using the following scale: 1=extremely uncomfortable, 2= very uncomfortable, 3=slightly uncomfortable, 4=comfortable, 5=very comfortable.
End of Day Comfort
Rating of comfort at the end of the day using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent
Initial Comfort
Rating of "comfort immediately when you first put them on" using the following scale: 0=N/A, 1= Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.
Inferior Region Corneal Staining
National Eye Institute (NEI) 0-3 scale: grade 0=normal, grade 1=mild, grade 2=moderate, grade 3=severe.

Full Information

First Posted
July 30, 2008
Last Updated
May 5, 2015
Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Visioncare Research Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00727558
Brief Title
A Comparison of Daily Disposable Contact Lenses.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 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

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
Myopia
Keywords
refractive error

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
narafilcon A
Arm Type
Active Comparator
Arm Description
spherical soft contact lens worn as a daily disposable modality for one week
Arm Title
nelfilcon A
Arm Type
Active Comparator
Arm Description
spherical soft contact lens worn as a daily disposable modality for one week
Intervention Type
Device
Intervention Name(s)
nelfilcon A
Intervention Description
spherical soft contact lens
Intervention Type
Device
Intervention Name(s)
narafilcon A
Intervention Description
spherical soft contact lens
Primary Outcome Measure Information:
Title
Overall Comfort
Description
Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent
Time Frame
at 1 week of wear.
Title
Measured Limbal Hyperemia
Description
Measurement of redness of the limbus, graded using half-grade increments using the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.
Time Frame
at 1 week of wear.
Secondary Outcome Measure Information:
Title
Overall Handling
Description
Rating of overall ease of handling using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.
Time Frame
at 1 week of wear
Title
How Comfortable Eyes Feel at the End of the Day
Description
Rating of "How comfortable did your eyes feel at the end of the day when wearing the contact lenses provided" using the following scale: 1=extremely uncomfortable, 2= very uncomfortable, 3=slightly uncomfortable, 4=comfortable, 5=very comfortable.
Time Frame
at 1 week wear
Title
End of Day Comfort
Description
Rating of comfort at the end of the day using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent
Time Frame
at 1 week of wear
Title
Initial Comfort
Description
Rating of "comfort immediately when you first put them on" using the following scale: 0=N/A, 1= Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.
Time Frame
at 1 week
Title
Inferior Region Corneal Staining
Description
National Eye Institute (NEI) 0-3 scale: grade 0=normal, grade 1=mild, grade 2=moderate, grade 3=severe.
Time Frame
at 1 week of wear

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 3-4
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
The Contact Lens Centre
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL1 1LB
Country
United Kingdom
Facility Name
Keith Tempany Opticians
City
Broadstone
State/Province
Dorset
ZIP/Postal Code
BH18 8DH
Country
United Kingdom
Facility Name
Eyecare
City
Ilford
State/Province
Essex
ZIP/Postal Code
IG1 4DU
Country
United Kingdom
Facility Name
Leightons Opticians
City
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
Bowden & Lowe
City
Gillingham
State/Province
Kent
ZIP/Postal Code
ME7 2YX
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
David H Burns BSC, FCOptom
City
Tottenham
State/Province
London
ZIP/Postal Code
N17 0EY
Country
United Kingdom
Facility Name
First Contact Opticians
City
Eastcote Pinner
State/Province
Middlesex
ZIP/Postal Code
HA5 1RJ
Country
United Kingdom
Facility Name
Chalmers & Son (Opticians)
City
Cardiff
State/Province
South Glamorgan
ZIP/Postal Code
CF24 3RQ
Country
United Kingdom
Facility Name
Susan R Bowers Opticians
City
Coventry
State/Province
West Midlands
ZIP/Postal Code
CV4 9DU
Country
United Kingdom
Facility Name
Ellis & Killpartrick
City
Bath
ZIP/Postal Code
BA1 1BA
Country
United Kingdom
Facility Name
Hawkes & Wainer
City
London
ZIP/Postal Code
EC3V 1LT
Country
United Kingdom
Facility Name
City Opticians
City
London
ZIP/Postal Code
WC2A 1AA
Country
United Kingdom
Facility Name
Tompkins Knight & Son
City
Northampton
ZIP/Postal Code
NN2 7BL
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 Daily Disposable Contact Lenses.

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