Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.
NCT ID: NCT00708032
Last Updated: 2019-12-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
74 participants
INTERVENTIONAL
2008-06-01
2009-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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spectacles
habitual spectacles worn daily for 12 months
spectacles
habitual spectacles
narafilcon A soft contact lenses
narafilcon A soft contact lenses worn as daily disposable for 12 months
narafilcon A soft contact lenses
narafilcon A daily disposable contact lenses
Interventions
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spectacles
habitual spectacles
narafilcon A soft contact lenses
narafilcon A daily disposable contact lenses
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
39 Years
ALL
No
Sponsors
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University of Manchester
OTHER
Johnson & Johnson Vision Care, Inc.
INDUSTRY
Responsible Party
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Locations
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Eurolens Research, The University of Manchester
Manchester, Greater Manchester, United Kingdom
Countries
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Other Identifiers
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CR-0806
Identifier Type: -
Identifier Source: org_study_id