A Comparison of Two Daily Disposable Contact Lenses

Myopia Clinical Trial

Official title:

The Comparative Clinical Performance of Narafilcon A and the FOCUS DAILIES AquaComfort Plus Lens

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00634101
• Other study ID #: CR-0716
• Secondary ID: DISP-519
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2008
• Est. completion date: March 1, 2008

Study information

• Verified date: December 2020
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 129
• Est. completion date: March 1, 2008
• Est. primary completion date: March 1, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• nelfilcon A
contact lens
• narafilcon A
contact lens

Locations

Country	Name	City	State
United Kingdom	Simon Donne Opticians	Bedford	Bedfordshire
United Kingdom	Boots Opticians Ltd	Birmingham	West Midlands
United Kingdom	Cole Martin Tregaskis Optometrists	Brentwood	Essex
United Kingdom	Brock & Houlford	Brislington	Bristol
United Kingdom	Keith Tempany Opticians	Broadstone	Dorset
United Kingdom	Chalmers & Sons (Opticians)	Cardiff	South Glamorgan
United Kingdom	Specsavers Opticians	Colchester	Essex
United Kingdom	Vision Express Optical Lab	Hendon	London
United Kingdom	City Opticians	Holborn	London
United Kingdom	Eyecare	Ilford	Essex
United Kingdom	Tompkins Knight & Son	Northampton	Northamptonhsire
United Kingdom	Dipple & Conway Opticians	Norwich	Norfolk
United Kingdom	First Contact Opticians	Pinner	Middlesex
United Kingdom	David Gould Opticians	Rawtenstall	Lancashire
United Kingdom	Hazel Smith Opticians	Shanklin	Isle Of Wight
United Kingdom	Cameron-Davies Optometrists	Southsea	Hants
United Kingdom	Leightons Opticians	St. Albans	Herts
United Kingdom	David H. Burns, BSC, FCOptom	Tottenham	London
United Kingdom	S.H. Harrold	Uxbridge	Middlesex
United Kingdom	Viewpoint	York

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.	Visioncare Research Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1-Week Follow-up
Primary	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).	1-Week Follow-up
Primary	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.	1-Week Follow-up
Primary	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.	1-Week Follow-up
Primary	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.	1-Week Follow-up
Primary	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.	1-Week Follow-up
Primary	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.	1-Week Follow-up
Primary	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.	1-Week Follow-up
Primary	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.	1-Week Follow-up
Primary	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.	1-Week Follow-up
Primary	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.	1-Week Follow-up
Primary	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.	1-Week Follow-up
Secondary	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).	1-Week Follow-up