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A Comparison of Two Daily Disposable Contact Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00634101
Recruitment Status : Terminated (Study was resurrected as NCT00727558 (CR-0808))
First Posted : March 12, 2008
Last Update Posted : June 20, 2017
Visioncare Research Ltd.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

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.

Condition or disease Intervention/treatment
Refractive Error Myopia Device: nelfilcon A Device: narafilcon A

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Comparative Clinical Performance of Narafilcon A and the FOCUS DAILIES AquaComfort Plus Lens
Actual Study Start Date : January 1, 2008
Primary Completion Date : March 1, 2008
Study Completion Date : March 1, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: nefilcon A
Subjects randomized to this arm received the nelfilcon A lens throughout the entire duration of the study.
Device: nelfilcon A
contact lens
Other Name: FOCUS DAILIES AquaComfort Plus
Experimental: narafilcon A
Subjects randomized to this arm received the narafilcon A lens throughout the entire duration of the study.
Device: narafilcon A
contact lens
Other Name: Experimental Contact Lens

Primary Outcome Measures :
  1. Patient- Report Comfort [ Time Frame: 1- Week Follow-up ]
    Patient- Reported Comfort will be assessed by a questionnaire.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634101

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
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
York, United Kingdom, YO1 8BA
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
Visioncare Research Ltd.

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00634101     History of Changes
Other Study ID Numbers: CR-0716
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases