Lens Fitting Evaluation of CooperVision MyDay™ Compared With 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®
NCT ID: NCT02341859
Last Updated: 2017-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2015-01-31
2015-07-31
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 and delefilcon A
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A
contact lens
delefilcon A
contact lens
stenfilcon A and narafilcon A
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A
contact lens
narafilcon A
contact lens
Interventions
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stenfilcon A
contact lens
delefilcon A
contact lens
narafilcon A
contact lens
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has had a self-reported visual exam in the last two years
* Is an adapted soft spherical contact lens wearer
* Has a contact lens spherical prescription between -4.00 to - 6.00 and higher than -7.00D (Diopters) (inclusive)
* Has a BFS (Best Fit Sphere) that is higher than 8.2 measured and calculated by corneal topography
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter
* Patient contact lens refraction should fit within the available parameters of the study lenses
* Is willing to comply with the wear schedule
* Is willing to comply with the visit schedule
Exclusion Criteria
* Has a contact lens prescription outside the range of the available parameters of the study lenses
* Has a contact lens prescription outside the range of the inclusion power range
* Has a spectacle cylinder ≥1.00D of cylinder in either eye
* Has a history of not achieving comfortable contact lens wear (5 days per week; \> 8 hours/day)
* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye
* Presence of clinically significant (grade \> 2) anterior segment abnormalities
* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear
* Slit lamp findings that would contraindicate contact lens wear such as:
* Moderate to severe dry eye
* Pterygium, pinguecula, or corneal scars within the visual axis
* Neovascularization \> 0.75 mm in from of the limbus
* Giant papillary conjunctivitis (GCP) worse than grade 1
* Anterior uveitis or iritis (past or present)
* Seborrheic eczema, Seborrheic conjunctivitis
* History of corneal ulcers or fungal infections
* Poor personal hygiene
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea
* Has Presbyopia or has dependence on spectacles for near work over the contact lenses
* Has undergone corneal refractive surgery
* Is participating in any other type of eye related clinical or research 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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Meng C Lin, OD PhD
Role: PRINCIPAL_INVESTIGATOR
CRC-UC Berkeley
Locations
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Clinical Research Center, University of California, Berkeley
Berkeley, California, United States
Countries
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Other Identifiers
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JP-MKTG-201501
Identifier Type: -
Identifier Source: org_study_id
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