A Comparison of Two Daily Disposable Contact Lenses
This study has been terminated.
Sponsor:
Vistakon
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
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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:
- 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
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 May 23, 2013