Clinical Evaluation of Investigational Multifocal Toric Contact Lenses
NCT ID: NCT03519282
Last Updated: 2020-05-04
Study Results
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View full resultsBasic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2018-04-25
2018-07-24
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
TREATMENT
SINGLE
Study Groups
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Test Multifocal Toric Lens
comfilcon A multifocal toric lens
comfilcon A multifocal toric lens
contact lens
omafilcon A Multifocal Toric Lens
contact lens
omafilcon A Multifocal Toric Lens
Control multifocal toric lens
comfilcon A multifocal toric lens
contact lens
omafilcon A Multifocal Toric Lens
contact lens
Interventions
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comfilcon A multifocal toric lens
contact lens
omafilcon A Multifocal Toric Lens
contact lens
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is aged 40-75 years, inclusive and has full legal capacity to volunteer.
* Has read and understood the participant information sheet.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Is able to participate in Parts A and B related to this work.
* Has a contact lens spherical prescription between +10.00 to -10.00D (inclusive).
* Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).
* Has astigmatism between -0.75 and -5.75DC (based on the vertexed ocular refraction in each eye.
* Can be satisfactorily fitted with the study lenses.
* Is correctable to a visual acuity of 20/40 (0.30 logMAR) or better (in each eye) with their habitual vision correction or 20/25 (0.10 logMAR) best-corrected.
* They have successfully worn soft contact lenses in the last six months
* Has clear corneas and no active ocular disease.
* Has not worn lenses for at least 12 hours before the examination.
* Has an up-to-date pair of spectacles.
Exclusion Criteria
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that will affect ocular health.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would, in the opinion of the investigator, affect the wearing of contact lenses.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye that would, in the opinion of the investigator, be problematic for their participation in the study.
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Is aphakic.
* Has undergone corneal refractive surgery.
* Has a history of anaphylaxis or severe allergic reaction.
* Has diabetes or an infectious or immunosuppressive disease which could contraindicate contact lens wear or pose a risk to the investigator.
* They are pregnant or breast-feeding.
* Is participating in any other type of eye-related clinical or research study.
40 Years
75 Years
ALL
No
Sponsors
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CooperVision, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Philip Morgan, BSc, PhD, MCOptom
Role: PRINCIPAL_INVESTIGATOR
Eurolens Research
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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CV-18-11
Identifier Type: -
Identifier Source: org_study_id
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