A Comparison of Two Daily Disposable Contact Lenses

NCT ID: NCT00600080

Last Updated: 2015-05-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-03-31

Brief Summary

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This study seeks to evaluate the clinical performance of a recently improved daily disposable contact lens to an established daily disposable contact lens that contains a wetting agent.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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etafilcon A first nelfilcon A second

etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2

Group Type OTHER

etafilcon A

Intervention Type DEVICE

contact lens worn daily for one week (first or second week depending on arm)

nelfilcon A

Intervention Type DEVICE

Contact lens worn daily for one week (first or second week depending on arm)

nelfilcon A first, etafilcon A second

nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2

Group Type OTHER

etafilcon A

Intervention Type DEVICE

contact lens worn daily for one week (first or second week depending on arm)

nelfilcon A

Intervention Type DEVICE

Contact lens worn daily for one week (first or second week depending on arm)

Interventions

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etafilcon A

contact lens worn daily for one week (first or second week depending on arm)

Intervention Type DEVICE

nelfilcon A

Contact lens worn daily for one week (first or second week depending on arm)

Intervention Type DEVICE

Other Intervention Names

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1-DAY ACUVUE MOIST DAILIES AquaComfort Plus

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manchester

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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Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CR-0729

Identifier Type: -

Identifier Source: org_study_id

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