Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses
NCT ID: NCT01707238
Last Updated: 2020-08-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2012-10-31
2013-03-31
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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stenfilcon A
Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
etafilcon A
Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
etafilcon A
Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
stenfilcon A
Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
Interventions
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etafilcon A
Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
stenfilcon A
Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adapted soft contact lens (CL) wearers (i.e. \> 1 month)
* Spherical distance CL prescription between -1.00 and -6.00D (inclusive)
* Spectacle cylinder ≤0.75D in the least astigmatic eye, ≤1.00D in the other.
* Correctable to 6/9 (20/30) in both eyes
* Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study.
* Have read, understood and signed the informed consent
* Willing to comply with the wear schedule (at least 40 hours per week)
* Willing to comply with the study visit schedule
Exclusion Criteria
* Systemic or ocular allergies, which might interfere with CL wear
* Systemic disease, which might interfere with CL wear
* Ocular disease, which might interfere with CL wear
* Strabismus, amblyopia
* Subjects who have undergone corneal refractive surgery and any anterior segment surgery
* Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
* Pregnant or lactating
* Use of systemic/topical medication contraindicating CL wear
* Use of gas permeable contact lenses within the last month
* Employees of the investigational site or immediate family members of Investigators
* Participation in any concurrent clinical trial or in the last 30 days
16 Years
45 Years
ALL
No
Sponsors
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CooperVision, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Graeme Young
Role: STUDY_DIRECTOR
Visioncare Research Ltd.
Ruth Craven
Role: STUDY_DIRECTOR
Visioncare Research Ltd.
Locations
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Keith Tempany Opticians
Broadstone, Dorset, United Kingdom
Cameron-Davies Optometrists
Southsea, Hampshire, United Kingdom
Cameron-Davies Optometrists
Portchester, Hants, United Kingdom
Leightons Opticians
St Albans, Hertfordshire, United Kingdom
David Gould Opticians
Rawtenstall, Lancashire, United Kingdom
Vision Express Optical Lab
Hendon, London, United Kingdom
S.H. Harrold
Uxbridge, London, United Kingdom
Countries
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Other Identifiers
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EX-MKTG-39
Identifier Type: -
Identifier Source: org_study_id
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