Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses
NCT ID: NCT02542072
Last Updated: 2017-10-24
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
90 participants
INTERVENTIONAL
2015-08-31
2016-03-31
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
SINGLE
Study Groups
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comfilcon A
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A
contact lens
samfilcon A
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A
contact lens
Interventions
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comfilcon A
contact lens
samfilcon A
contact lens
Eligibility Criteria
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Inclusion Criteria
* Adapted soft Contact Lens wearers (i.e. \>1 month), daily disposable and reusable lens wearers.
* Spectacle cylinder 0.75D in both eyes.
* Correctable to 6/9 (20/30) in both eyes
* Be between 18 and 50 years of age (inclusive)
* Able to read, comprehend and sign an informed consent
* Own a mobile phone and be willing to respond to Short Message Service (SMS) survey
* Willing to comply with the wear and study visit schedule
Exclusion:
* Existing Biofinity or Ultra wearers
* Any active corneal infection, injury or inflammation
* Systemic or ocular allergies, which might interfere with Contact Lens wear
* Systemic disease, which might interfere with Contact Lens wear
* Ocular disease, which might interfere with Contact Lens wear
* Strabismus or amblyopia
* Subjects who have undergone corneal refractive surgery
* Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
* Pregnant or lactating
* Use of systemic/topical medication contraindicating Contact Lens wear
* Diabetic
* Site employees or family members of site employees
18 Years
50 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: PRINCIPAL_INVESTIGATOR
VisionCare
Locations
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Golden Optometric Group
Whittier, California, United States
Complete Eye Care of Medina
Medina, Minnesota, United States
Brock & Houlford
Chew Magna, Bristol, United Kingdom
Tempany's Boutique Opticians
Broadstone, Dorset, United Kingdom
David Gould Opticians
Rawtenstall, Lancashire, United Kingdom
Countries
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Other Identifiers
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EX-MKTG-59 (VISA-406)
Identifier Type: -
Identifier Source: org_study_id