A Comparison of Daily Disposable Contact Lenses.

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: narafilcon A; Device: nelfilcon A

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: narafilcon A; spherical soft contact lens; Device: nelfilcon A; spherical soft contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Comfort	Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent	at 1 week of wear.
Measured Limbal Hyperemia	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.	at 1 week of wear.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Handling	Rating of overall ease of handling using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.	at 1 week of wear
How Comfortable Eyes Feel at the End of the Day	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.	at 1 week wear
End of Day Comfort	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	at 1 week of wear
Initial Comfort	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.	at 1 week
Inferior Region Corneal Staining	National Eye Institute (NEI) 0-3 scale: grade 0=normal, grade 1=mild, grade 2=moderate, grade 3=severe.	at 1 week of wear

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Collaborators: Visioncare Research Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: July 30, 2008
• First Submitted That Met QC Criteria: August 1, 2008
• First Posted (Estimate): August 4, 2008

Study Record Updates

• Last Update Posted (Estimate): May 21, 2015
• Last Update Submitted That Met QC Criteria: May 5, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: refractive error
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CR-0808; PROD-501