- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00634101
A Comparison of Two Daily Disposable Contact Lenses
December 9, 2020 updated by: Johnson & Johnson Vision Care, Inc.
The Comparative Clinical Performance of Narafilcon A and the FOCUS DAILIES AquaComfort Plus Lens
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
129
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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York, United Kingdom, YO1 8BA
- Viewpoint
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Bedfordshire
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Bedford, Bedfordshire, United Kingdom, MK40 1NS
- Simon Donne Opticians
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Bristol
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Brislington, Bristol, United Kingdom, BS4 3LJ
- Brock & Houlford
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Dorset
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Broadstone, Dorset, United Kingdom, BH18 8DH
- Keith Tempany Opticians
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Essex
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Brentwood, Essex, United Kingdom, CM15 8AG
- Cole Martin Tregaskis Optometrists
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Colchester, Essex, United Kingdom, CO1 1LJ
- Specsavers Opticians
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Ilford, Essex, United Kingdom, IG1 4DU
- Eyecare
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Hants
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Southsea, Hants, United Kingdom, PO5 2AT
- Cameron-Davies Optometrists
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Herts
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St. Albans, Herts, United Kingdom, AL1 3LH
- Leightons Opticians
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Isle Of Wight
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Shanklin, Isle Of Wight, United Kingdom, PO37 6JZ
- Hazel Smith Opticians
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Lancashire
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Rawtenstall, Lancashire, United Kingdom, BB4 7QN
- David Gould Opticians
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London
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Hendon, London, United Kingdom, NW4 3FB
- Vision Express Optical Lab
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Holborn, London, United Kingdom, WC2A 1AA
- City Opticians
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Tottenham, London, United Kingdom, N17 0EY
- David H. Burns, BSC, FCOptom
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Middlesex
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Pinner, Middlesex, United Kingdom, HA5 1RJ
- First Contact Opticians
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Uxbridge, Middlesex, United Kingdom, UB81JX
- S.H. Harrold
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Norfolk
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Norwich, Norfolk, United Kingdom, NR2 1PB
- Dipple & Conway Opticians
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Northamptonhsire
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Northampton, Northamptonhsire, United Kingdom, NN2 7BL
- Tompkins Knight & Son
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South Glamorgan
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Cardiff, South Glamorgan, United Kingdom, CF24 3RQ
- Chalmers & Sons (Opticians)
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West Midlands
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Birmingham, West Midlands, United Kingdom, B4 7TB
- Boots Opticians Ltd
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: nefilcon A
Subjects randomized to this arm received the nelfilcon A lens throughout the entire duration of the study.
|
contact lens
Other Names:
|
Experimental: narafilcon A
Subjects randomized to this arm received the narafilcon A lens throughout the entire duration of the study.
|
contact lens
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comfort at the End of the Day
Time Frame: 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.
|
1-Week Follow-up
|
Limbal Hyperaemia
Time Frame: 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).
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1-Week Follow-up
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Comfort Immediately When You First Put Them on
Time Frame: 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.
|
1-Week Follow-up
|
Comfort Throughout the Day
Time Frame: 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.
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1-Week Follow-up
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Lack of Dryness at the End of the Day
Time Frame: 1-Week Follow-up
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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.
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1-Week Follow-up
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Overall Opinion
Time Frame: 1-Week Follow-up
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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.
|
1-Week Follow-up
|
Overall Comfort
Time Frame: 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.
|
1-Week Follow-up
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My Lenses Stayed Moist
Time Frame: 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.
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1-Week Follow-up
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I Forgot i Was Wearing Lenses Was
Time Frame: 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.
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1-Week Follow-up
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Mainted Natural Moisture
Time Frame: 1-Week Follow-up
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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.
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1-Week Follow-up
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Comfort While Wearing Lenses in Heat/Air Conditioned Environments
Time Frame: 1-Week Follow-up
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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.
|
1-Week Follow-up
|
Dryness at the End of the Day
Time Frame: 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.
|
1-Week Follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Handling
Time Frame: 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).
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1-Week Follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2008
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
February 28, 2008
First Submitted That Met QC Criteria
March 11, 2008
First Posted (Estimate)
March 12, 2008
Study Record Updates
Last Update Posted (Actual)
January 6, 2021
Last Update Submitted That Met QC Criteria
December 9, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-0716
- DISP-519
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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