A Comparison of Daily Disposable Contact Lenses.

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727558
• Other study ID #: CR-0808
• Secondary ID: PROD-501
• Status: Completed
• Phase: N/A
• First received: July 30, 2008
• Last updated: May 5, 2015
• Start date: July 2008
• Est. completion date: October 2008

Study information

• Verified date: May 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• 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: Completed
• Enrollment: 248
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Leightons Opticians	Albans	Herts
United Kingdom	Ellis & Killpartrick	Bath
United Kingdom	Simon Donne Opticians 3-4	Bedford	Bedfordshire
United Kingdom	Brock & Houlford	Brislington	Bristol
United Kingdom	Keith Tempany Opticians	Broadstone	Dorset
United Kingdom	Chalmers & Son (Opticians)	Cardiff	South Glamorgan
United Kingdom	Susan R Bowers Opticians	Coventry	West Midlands
United Kingdom	First Contact Opticians	Eastcote Pinner	Middlesex
United Kingdom	Bowden & Lowe	Gillingham	Kent
United Kingdom	Vision Express Optical Lab	Hendon	London
United Kingdom	Eyecare	Ilford	Essex
United Kingdom	City Opticians	London
United Kingdom	Hawkes & Wainer	London
United Kingdom	Tompkins Knight & Son	Northampton
United Kingdom	The Contact Lens Centre	Plymouth	Devon
United Kingdom	David Gould Opticians	Rawtenstall	Lancashire
United Kingdom	Hazel Smith Opticians	Shanklin	Isle of Wight
United Kingdom	David H Burns BSC, FCOptom	Tottenham	London
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	Overall Comfort	Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent	at 1 week of wear.	No
Primary	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.	at 1 week of wear.	No
Secondary	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.	at 1 week of wear	No
Secondary	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.	at 1 week wear	No
Secondary	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	at 1 week of wear	No
Secondary	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.	at 1 week	No
Secondary	Inferior Region Corneal Staining	National Eye Institute (NEI) 0-3 scale: grade 0=normal, grade 1=mild, grade 2=moderate, grade 3=severe.	at 1 week of wear	No