Clinical trial NCT00727558: A Comparison of Daily Disposable Contact Lenses.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: refractive error
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Visioncare Research Ltd.
First posted: 2008-08-04
Enrollment: 248
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:

* 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.

Primary outcomes:
measure: Overall Comfort
timeFrame: at 1 week of wear.
measure: Measured Limbal Hyperemia
timeFrame: at 1 week of wear.
Secondary outcomes:
measure: Overall Handling
timeFrame: at 1 week of wear
measure: How Comfortable Eyes Feel at the End of the Day
timeFrame: at 1 week wear
measure: End of Day Comfort
timeFrame: at 1 week of wear
measure: Initial Comfort
timeFrame: at 1 week
measure: Inferior Region Corneal Staining
timeFrame: at 1 week of wear
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: Simon Donne Opticians 3-4
state: Bedfordshire
city: Brislington
country: United Kingdom
facility: Brock & Houlford
state: Bristol
city: Plymouth
country: United Kingdom
facility: The Contact Lens Centre
state: Devon
city: Broadstone
country: United Kingdom
facility: Keith Tempany Opticians
state: Dorset
city: Ilford
country: United Kingdom
facility: Eyecare
state: Essex
city: Albans
country: United Kingdom
facility: Leightons Opticians
state: Herts
city: Shanklin
country: United Kingdom
facility: Hazel Smith Opticians
state: Isle of Wight
city: Gillingham
country: United Kingdom
facility: Bowden & Lowe
state: Kent
city: Rawtenstall
country: United Kingdom
facility: David Gould Opticians
state: Lancashire
city: Hendon
country: United Kingdom
facility: Vision Express Optical Lab
state: London
city: Tottenham
country: United Kingdom
facility: David H Burns BSC, FCOptom
state: London
city: Eastcote Pinner
country: United Kingdom
facility: First Contact Opticians
state: Middlesex
city: Cardiff
country: United Kingdom
facility: Chalmers & Son (Opticians)
state: South Glamorgan
city: Coventry
country: United Kingdom
facility: Susan R Bowers Opticians
state: West Midlands
city: Bath
country: United Kingdom
facility: Ellis & Killpartrick
city: London
country: United Kingdom
facility: Hawkes & Wainer
city: London
country: United Kingdom
facility: City Opticians
city: Northampton
country: United Kingdom
facility: Tompkins Knight & Son
city: York
country: United Kingdom
facility: Viewpoint
Study officials:
References: