A Clinical Comparison of Two Daily Disposable Soft Contact Lenses
NCT ID: NCT04005885
Last Updated: 2021-01-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2019-03-01
2019-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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somofilcon A then stenfilcon A contact lens
Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear and stenfilcon A daily disposable test lens for 1 week of daily wear.
comfilcon A
Contact Lens
somofilcon A
daily disposable contact lens
stenfilcon A
daily disposable contact lens
stenfilcon A then somofilcon A contact lens
Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear and somofilcon A daily disposable test lens for 1 week of daily wear.
comfilcon A
Contact Lens
somofilcon A
daily disposable contact lens
stenfilcon A
daily disposable contact lens
Interventions
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comfilcon A
Contact Lens
somofilcon A
daily disposable contact lens
stenfilcon A
daily disposable contact lens
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* They are between 18 and 40 years of age (inclusive).
* They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
* They are willing and able to follow the protocol.
* They are an existing soft reusable spherical contact lens wearer in both eyes.
* They have a contact lens spherical prescription between -0.50 to -6.00D (inclusive) based on the ocular refraction.
* They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction
* They own a wearable pair of spectacles and wear them on the day of the initial visit.
* They have distance high contrast logMAR visual acuity of 0.2 or better in each eye with their habitual spectacles.
* They agree not to participate in other clinical research for the duration of the study.
Exclusion Criteria
* 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 have keratoconus.
* They are pregnant or breastfeeding.
* They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
* They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
18 Years
40 Years
ALL
No
Sponsors
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CooperVision, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Carole Maldonado-Codina, PhD, MCOptom, FAAO, FBCLA
Role: PRINCIPAL_INVESTIGATOR
Eurolens Research
Locations
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Eurolens Research - The University of Manchester
Manchester, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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EX-MKTG-100
Identifier Type: -
Identifier Source: org_study_id
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