The Clinical Comparison of Somofilcon A 1 Day and Nelfilcon A Daily Disposable Contact Lenses
NCT ID: NCT04067141
Last Updated: 2020-11-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2019-07-04
2019-11-20
Brief Summary
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Detailed Description
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Subjects will use each lens type for a week in random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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somofilcon A, then nelfilcon A
Subjects will bilaterally wear the somofilcon A lenses, then crossover to nelfilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week.
somofilcon A
Contact Lens
nelfilcon A
Contact Lens
nelfilcon A, then somofilcon A
Subjects will bilaterally wear the nelfilcon A lenses, then crossover to somofilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week.
somofilcon A
Contact Lens
nelfilcon A
Contact Lens
Interventions
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somofilcon A
Contact Lens
nelfilcon A
Contact Lens
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 agree not to participate in other clinical research for the duration of this study.
* They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)
* They have a maximum of -1.00DC ocular astigmatism in each eye.
* They can be satisfactorily fitted with the study lens types.
* At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
* They currently use soft contact lenses or have done so in the previous six months.
* They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
* They own a wearable pair of spectacles.
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 have had cataract surgery.
* 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 breast-feeding.
* They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
* 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.
* They currently wear either the clariti 1day or the DAILIES AquaComfort Plus lens.
18 Years
ALL
No
Sponsors
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CooperVision, Inc.
INDUSTRY
Responsible Party
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Locations
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Eurolens Research
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-75
Identifier Type: -
Identifier Source: org_study_id