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A Comparison of Daily Disposable Contact Lenses.
This study has been completed.
Sponsors and Collaborators: Vistakon
Visioncare Research Ltd.
Information provided by: Vistakon
ClinicalTrials.gov Identifier: NCT00727558
  Purpose

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.


Condition Intervention
Myopia
Device: nelfilcon A
Device: narafilcon A

MedlinePlus related topics: Eye Wear
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment

Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Patient-reported comfort [ Time Frame: Measured at baseline and after 1 week of wear. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measured limbal hyperemia [ Time Frame: Measured at baseline and after 1 week of wear. ] [ Designated as safety issue: No ]

Enrollment: 251
Study Start Date: July 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
contact lens
Device: nelfilcon A
contact lens
2: Experimental
contact lens
Device: narafilcon A
contact lens

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 immunosupporessive 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727558

Locations
United Kingdom
Ellis & Killpartrick
Bath, United Kingdom, BA1 1BA
Hawkes & Wainer
London, United Kingdom, EC3V 1LT
City Opticians
London, United Kingdom, WC2A 1AA
Tompkins Knight & Son
Northampton, United Kingdom, NN2 7BL
Viewpoint
York, United Kingdom, YO1 8BA
United Kingdom, Bedfordshire
Simon Donne Opticians 3-4
Bedford, Bedfordshire, United Kingdom, MK40 1NS
United Kingdom, Bristol
Brock & Houlford
Brislington, Bristol, United Kingdom, BS4 3LJ
United Kingdom, Devon
The Contact Lens Centre
Plymouth, Devon, United Kingdom, PL1 1LB
United Kingdom, Dorset
Keith Tempany Opticians
Broadstone, Dorset, United Kingdom, BH18 8DH
United Kingdom, Essex
Eyecare
Ilford, Essex, United Kingdom, IG1 4DU
United Kingdom, Herts
Leightons Opticians
Albans, Herts, United Kingdom, AL1 3LH
United Kingdom, Isle of Wight
Hazel Smith Opticians
Shanklin, Isle of Wight, United Kingdom, PO37 6JZ
United Kingdom, Kent
Bowden & Lowe
Gillingham, Kent, United Kingdom, ME7 2YX
United Kingdom, Lancashire
David Gould Opticians
Rawtenstall, Lancashire, United Kingdom, BB4 7QN
United Kingdom, London
David H Burns BSC, FCOptom
Tottenham, London, United Kingdom, N17 0EY
Vision Express Optical Lab
Hendon, London, United Kingdom, NW4 3FB
United Kingdom, Middlesex
First Contact Opticians
Eastcote Pinner, Middlesex, United Kingdom, HA5 1RJ
United Kingdom, South Glamorgan
Chalmers & Son (Opticians)
Cardiff, South Glamorgan, United Kingdom, CF24 3RQ
United Kingdom, West Midlands
Susan R Bowers Opticians
Coventry, West Midlands, United Kingdom, CV4 9DU
Sponsors and Collaborators
Vistakon
Visioncare Research Ltd.
  More Information

Responsible Party: Vistakon ( Kurt Moody, OD, FAAO./ Associate Director, Clinical Research )
Study ID Numbers: CR-0808, PROD-501
Study First Received: July 30, 2008
Last Updated: October 31, 2008
ClinicalTrials.gov Identifier: NCT00727558  
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Vistakon:
refractive error

Study placed in the following topic categories:
Myopia
Refractive Errors

ClinicalTrials.gov processed this record on January 14, 2009