A Comparison of Two Daily Disposable Contact Lenses

This study has been terminated.
Sponsor:
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00634101
First received: February 28, 2008
Last updated: August 30, 2011
Last verified: August 2011
  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
Refractive Error
Myopia
Device: nelfilcon A
Device: narafilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Comparative Clinical Performance of Narafilcon A and the FOCUS DAILIES AquaComfort Plus Lens

Resource links provided by NLM:


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 ]

Estimated Enrollment: 280
Study Start Date: January 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
nelfilcon A
Device: nelfilcon A
contact lens
Other Name: FOCUS DAILIES AquaComfort Plus
Experimental: 2
narafilcon A
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634101

Locations
United Kingdom
Simon Donne Opticians
Bedford, Bedfordshire, United Kingdom, MK40 1NS
Brock & Houlford
Brislington, Bristol, United Kingdom, BS4 3LJ
Keith Tempany Opticians
Broadstone, Dorset, United Kingdom, BH18 8DH
Cole Martin Tregaskis Optometrists
Brentwood, Essex, United Kingdom, CM15 8AG
Specsavers Opticians
Colchester, Essex, United Kingdom, CO1 1LJ
Eyecare
Ilford, Essex, United Kingdom, IG1 4DU
Cameron-Davies Optometrists
Southsea, Hants, United Kingdom, PO5 2AT
Leightons Opticians
St. Albans, Herts, United Kingdom, AL1 3LH
Hazel Smith Opticians
Shanklin, Isle of Wight, United Kingdom, PO37 6JZ
David Gould Opticians
Rawtenstall, Lancashire, United Kingdom, BB4 7QN
Vision Express Optical Lab
Hendon, London, United Kingdom, NW4 3FB
City Opticians
Holborn, London, United Kingdom, WC2A 1AA
David H. Burns, BSC, FCOptom
Tottenham, London, United Kingdom, N17 0EY
First Contact Opticians
Pinner, Middlesex, United Kingdom, HA5 1RJ
S.H. Harrold
Uxbridge, Middlesex, United Kingdom, UB81JX
Dipple & Conway Opticians
Norwich, Norfolk, United Kingdom, NR2 1PB
Tompkins Knight & Son
Northampton, Northamptonhsire, United Kingdom, NN2 7BL
Chalmers & Sons (Opticians)
Cardiff, South Glamorgan, United Kingdom, CF24 3RQ
Boots Opticians Ltd
Birmingham, West Midlands, United Kingdom, B4 7TB
Viewpoint
York, United Kingdom, YO1 8BA
Sponsors and Collaborators
Vistakon
Visioncare Research Ltd.
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00634101     History of Changes
Other Study ID Numbers: CR-0716, DISP-519
Study First Received: February 28, 2008
Last Updated: August 30, 2011
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014