A Comparison of Two Daily Disposable Contact Lenses

NCT ID: NCT00634101

Last Updated: 2021-01-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-01

Study Completion Date

2008-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Refractive Error Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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nefilcon A

Subjects randomized to this arm received the nelfilcon A lens throughout the entire duration of the study.

Group Type ACTIVE_COMPARATOR

nelfilcon A

Intervention Type DEVICE

contact lens

narafilcon A

Subjects randomized to this arm received the narafilcon A lens throughout the entire duration of the study.

Group Type EXPERIMENTAL

narafilcon A

Intervention Type DEVICE

contact lens

Interventions

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nelfilcon A

contact lens

Intervention Type DEVICE

narafilcon A

contact lens

Intervention Type DEVICE

Other Intervention Names

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FOCUS DAILIES AquaComfort Plus Experimental Contact Lens

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Visioncare Research Ltd.

OTHER

Sponsor Role collaborator

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Simon Donne Opticians

Bedford, Bedfordshire, United Kingdom

Site Status

Brock & Houlford

Brislington, Bristol, United Kingdom

Site Status

Keith Tempany Opticians

Broadstone, Dorset, United Kingdom

Site Status

Cole Martin Tregaskis Optometrists

Brentwood, Essex, United Kingdom

Site Status

Specsavers Opticians

Colchester, Essex, United Kingdom

Site Status

Eyecare

Ilford, Essex, United Kingdom

Site Status

Cameron-Davies Optometrists

Southsea, Hants, United Kingdom

Site Status

Leightons Opticians

St Albans, Herts, United Kingdom

Site Status

Hazel Smith Opticians

Shanklin, Isle Of Wight, United Kingdom

Site Status

David Gould Opticians

Rawtenstall, Lancashire, United Kingdom

Site Status

Vision Express Optical Lab

Hendon, London, United Kingdom

Site Status

City Opticians

Holborn, London, United Kingdom

Site Status

David H. Burns, BSC, FCOptom

Tottenham, London, United Kingdom

Site Status

First Contact Opticians

Pinner, Middlesex, United Kingdom

Site Status

S.H. Harrold

Uxbridge, Middlesex, United Kingdom

Site Status

Dipple & Conway Opticians

Norwich, Norfolk, United Kingdom

Site Status

Tompkins Knight & Son

Northampton, Northamptonhsire, United Kingdom

Site Status

Chalmers & Sons (Opticians)

Cardiff, South Glamorgan, United Kingdom

Site Status

Boots Opticians Ltd

Birmingham, West Midlands, United Kingdom

Site Status

Viewpoint

York, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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DISP-519

Identifier Type: -

Identifier Source: secondary_id

CR-0716

Identifier Type: -

Identifier Source: org_study_id

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