Clinical trial NCT00634101: A Comparison of Two Daily Disposable Contact Lenses
Official title: The Comparative Clinical Performance of Narafilcon A and the FOCUS DAILIES AquaComfort Plus Lens
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Refractive Error
Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Visioncare Research Ltd.
First posted: 2008-03-12
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Comfort at the End of the Day
timeFrame: 1-Week Follow-up
measure: Limbal Hyperaemia
timeFrame: 1-Week Follow-up
measure: Comfort Immediately When You First Put Them on
timeFrame: 1-Week Follow-up
measure: Comfort Throughout the Day
timeFrame: 1-Week Follow-up
measure: Lack of Dryness at the End of the Day
timeFrame: 1-Week Follow-up
measure: Overall Opinion
timeFrame: 1-Week Follow-up
measure: Overall Comfort
timeFrame: 1-Week Follow-up
measure: My Lenses Stayed Moist
timeFrame: 1-Week Follow-up
measure: I Forgot i Was Wearing Lenses Was
timeFrame: 1-Week Follow-up
measure: Mainted Natural Moisture
timeFrame: 1-Week Follow-up
measure: Comfort While Wearing Lenses in Heat/Air Conditioned Environments
timeFrame: 1-Week Follow-up
measure: Dryness at the End of the Day
timeFrame: 1-Week Follow-up
Secondary outcomes:
measure: Overall Handling
timeFrame: 1-Week Follow-up
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: Simon Donne Opticians
state: Bedfordshire
city: Brislington
country: United Kingdom
facility: Brock & Houlford
state: Bristol
city: Broadstone
country: United Kingdom
facility: Keith Tempany Opticians
state: Dorset
city: Brentwood
country: United Kingdom
facility: Cole Martin Tregaskis Optometrists
state: Essex
city: Colchester
country: United Kingdom
facility: Specsavers Opticians
state: Essex
city: Ilford
country: United Kingdom
facility: Eyecare
state: Essex
city: Southsea
country: United Kingdom
facility: Cameron-Davies Optometrists
state: Hants
city: St. Albans
country: United Kingdom
facility: Leightons Opticians
state: Herts
city: Shanklin
country: United Kingdom
facility: Hazel Smith Opticians
state: Isle Of Wight
city: Rawtenstall
country: United Kingdom
facility: David Gould Opticians
state: Lancashire
city: Hendon
country: United Kingdom
facility: Vision Express Optical Lab
state: London
city: Holborn
country: United Kingdom
facility: City Opticians
state: London
city: Tottenham
country: United Kingdom
facility: David H. Burns, BSC, FCOptom
state: London
city: Pinner
country: United Kingdom
facility: First Contact Opticians
state: Middlesex
city: Uxbridge
country: United Kingdom
facility: S.H. Harrold
state: Middlesex
city: Norwich
country: United Kingdom
facility: Dipple & Conway Opticians
state: Norfolk
city: Northampton
country: United Kingdom
facility: Tompkins Knight & Son
state: Northamptonhsire
city: Cardiff
country: United Kingdom
facility: Chalmers & Sons (Opticians)
state: South Glamorgan
city: Birmingham
country: United Kingdom
facility: Boots Opticians Ltd
state: West Midlands
city: York
country: United Kingdom
facility: Viewpoint
Study officials:
References: