Daily Disposable Silicone Hydrogel Contact Lens, Stenfilcon A, Clinical Study
NCT ID: NCT02637804
Last Updated: 2017-10-23
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
106 participants
INTERVENTIONAL
2016-01-31
2016-08-31
Brief Summary
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This is a total 120 subject, randomized, open label, bilateral wear, two week crossover study (each lens for 1 week) evaluating the clinical performance of stenfilcon A spherical lenses compared to narafilcon A or delefilcon A spherical lenses.
Detailed Description
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The study participants will be allocated to two parallel groups (Group 1 and Group 2), 60 subjects each, based on the control lenses, narafilcon A and delefilcon A spherical lenses.
Study groups:
Group 1: stenfilcon A vs. narafilcon A
Group 2: stenfilcon A vs. delefilcon A
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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stenfilcon A vs narafilcon A (Group 1)
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A
contact lens
narafilcon A
contact lens
stenfilcon A vs delefilcon A (Group 2)
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A
contact lens
delefilcon A
contact lens
Interventions
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stenfilcon A
contact lens
narafilcon A
contact lens
delefilcon A
contact lens
Eligibility Criteria
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Inclusion Criteria
* Is over 18 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted daily disposable non-silicone hydrogel spherical contact lens wearer
* Can achieve best corrected spectacle distance visual acuity of 20/25 or better in each eye.
* Can achieve a distance visual acuity of 20/30 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.
* Has a CL (Contact Lens) spherical prescription between - 0.75 and - 8.00 (inclusive)
* Is willing to comply with the wear schedule.
* Is willing to comply with the visit schedule
Exclusion Criteria
* Is not a habitual wearer of daily disposable non-silicone hydrogel spherical contact lenses
* Has a CL 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 CL wear (5 days per week; \> 8 hours/day)
* Has contact lens best corrected distance vision worse than 20/25 in either eye
* Presence of clinically significant (grade 2-4) 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
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea.
* 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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Yuji Kodama, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Director, Kodama Eye Clinic
Other Identifiers
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JP-MKTG-201512
Identifier Type: -
Identifier Source: org_study_id