A Comparison of Two Daily Disposable Contact Lenses

Not Applicable

Terminated

• Conditions: Refractive Error; Myopia
• Interventions: Device: nelfilcon A; Device: narafilcon A

• Registration Number: NCT00634101
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-01
• Study First Submitted: 2008-02-28
• Primary Completion: 2008-03-01
• Study Completion: 2008-03-01
• Study First Submitted QC: 2008-03-11
• Study First Posted: 2008-03-12
• Disposition First Submitted: 2017-06-15
• Disposition First Submitted QC: 2017-06-15
• Disposition First Posted: 2017-06-20
• Results First Submitted: 2020-09-22
• Results First Submitted QC: 2020-09-22
• Results First Posted: 2020-10-14
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-09
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 129

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nefilcon A	nelfilcon A	Subjects randomized to this arm received the nelfilcon A lens throughout the entire duration of the study.
narafilcon A	narafilcon A	Subjects randomized to this arm received the narafilcon A lens throughout the entire duration of the study.

Primary Outcome Measures

Name	Time	Method
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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

Name	Time	Method
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).

Trial Locations

Locations (20)

Dipple & Conway Opticians; 🇬🇧 Norwich, Norfolk, United Kingdom

Keith Tempany Opticians; 🇬🇧 Broadstone, Dorset, United Kingdom

Simon Donne Opticians; 🇬🇧 Bedford, Bedfordshire, United Kingdom

Brock & Houlford; 🇬🇧 Brislington, Bristol, United Kingdom

Hazel Smith Opticians; 🇬🇧 Shanklin, Isle Of Wight, United Kingdom

Viewpoint; 🇬🇧 York, United Kingdom

Cole Martin Tregaskis Optometrists; 🇬🇧 Brentwood, Essex, United Kingdom

David Gould Opticians; 🇬🇧 Rawtenstall, Lancashire, United Kingdom

Leightons Opticians; 🇬🇧 St. Albans, Herts, United Kingdom

Vision Express Optical Lab; 🇬🇧 Hendon, London, United Kingdom

Specsavers Opticians; 🇬🇧 Colchester, Essex, United Kingdom

Cameron-Davies Optometrists; 🇬🇧 Southsea, Hants, United Kingdom

City Opticians; 🇬🇧 Holborn, London, United Kingdom

David H. Burns, BSC, FCOptom; 🇬🇧 Tottenham, London, United Kingdom

First Contact Opticians; 🇬🇧 Pinner, Middlesex, United Kingdom

S.H. Harrold; 🇬🇧 Uxbridge, Middlesex, United Kingdom

Eyecare; 🇬🇧 Ilford, Essex, United Kingdom

Boots Opticians Ltd; 🇬🇧 Birmingham, West Midlands, United Kingdom

Tompkins Knight & Son; 🇬🇧 Northampton, Northamptonhsire, United Kingdom

Chalmers & Sons (Opticians); 🇬🇧 Cardiff, South Glamorgan, United Kingdom