A Comparison of Daily Disposable Contact Lenses.

This study has been completed.
Sponsor:
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00727558
First received: July 30, 2008
Last updated: August 16, 2013
Last verified: August 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Overall Comfort [ Time Frame: at 1 week of wear. ] [ Designated as safety issue: No ]
    Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent

  • Measured Limbal Hyperemia [ Time Frame: at 1 week of wear. ] [ Designated as safety issue: No ]
    Measurement of redness of the limbus, graded using half-grade increments using the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.


Secondary Outcome Measures:
  • Overall Handling [ Time Frame: at 1 week of wear ] [ Designated as safety issue: No ]
    Rating of overall ease of handling using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.

  • How Comfortable Eyes Feel at the End of the Day [ Time Frame: at 1 week wear ] [ Designated as safety issue: No ]
    Rating of "How comfortable did your eyes feel at the end of the day when wearing the contact lenses provided" using the following scale: 1=extremely uncomfortable, 2= very uncomfortable, 3=slightly uncomfortable, 4=comfortable, 5=very comfortable.

  • End of Day Comfort [ Time Frame: at 1 week of wear ] [ Designated as safety issue: No ]
    Rating of comfort at the end of the day using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent

  • Initial Comfort [ Time Frame: at 1 week ] [ Designated as safety issue: No ]
    Rating of "comfort immediately when you first put them on" using the following scale: 0=N/A, 1= Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.

  • Inferior Region Corneal Staining [ Time Frame: at 1 week of wear ] [ Designated as safety issue: No ]
    National Eye Institute (NEI) 0-3 scale: grade 0=normal, grade 1=mild, grade 2=moderate, grade 3=severe.


Enrollment: 248
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
Active Comparator: narafilcon A
spherical soft contact lens worn as a daily disposable modality for one week
Device: narafilcon A
spherical soft contact lens
Active Comparator: nelfilcon A
spherical soft contact lens worn as a daily disposable modality for one week
Device: nelfilcon A
spherical soft contact lens
Device: narafilcon A
spherical soft 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 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.
  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: NCT00727558

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

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00727558     History of Changes
Other Study ID Numbers: CR-0808, PROD-501
Study First Received: July 30, 2008
Results First Received: September 24, 2009
Last Updated: August 16, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Vistakon:
refractive error

ClinicalTrials.gov processed this record on September 18, 2014