Three-month Clinical Evaluation of DSiHy Daily Disposable Silicone Hydrogel Contact Lenses
NCT ID: NCT03859440
Last Updated: 2019-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2019-05-31
2019-10-31
Brief Summary
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The results of this study will be analysed to determine how the 'test' lens compares with the 'control' lens. The control lens has been chosen because it is a market leader and is well tried and tested.
Participants who are in this study will need to have healthy eyes, except for the need to correct their eyesight. Up to 90 people who are aged 20 years or older will be considered for participation in this study. The study is designed to be approximately 3 months long.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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DSiHy (test lens)
DSiHy Silicone hydrogel soft contact lens
•Device: DSiHy (test lens) Silicone hydrogel soft contact lens for daily disposable wear.
Silicone hydrogel soft contact lens CE-marked for daily use
CE-marked Silicone hydrogel soft contact lens
・Device: Silicone hydrogel soft contact lens CE-marked for daily disposable wear.
Other Name : MyDay
Interventions
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DSiHy Silicone hydrogel soft contact lens
•Device: DSiHy (test lens) Silicone hydrogel soft contact lens for daily disposable wear.
CE-marked Silicone hydrogel soft contact lens
・Device: Silicone hydrogel soft contact lens CE-marked for daily disposable wear.
Other Name : MyDay
Eligibility Criteria
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Inclusion Criteria
* Sign written informed consent.
* Be a currently adapted soft contact lens wearer (i.e. be wearing lenses at least 1 month prior to enrolment).
* Contact lens sphere requirement between -1.00 to -6.00 D (inclusive).
* Refractive astigmatism (if present) less than or equal to 0.75 D in both eyes.
* Be correctable by sphero-cylindrical refraction to 6/7.5 (+0.10 logMAR 0.8 decimal) or better in each eye.
* Require visual correction in both eyes (monovision allowed, no monofit.
Exclusion Criteria
* Concurrent ocular medication.
* Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or contact lens performance.
* Any systemic illness affecting contact lens wear or the medical treatment of which would affect vision or successful lens wear (including diabetes).
* Clinically significant (≥Grade 2) corneal staining, corneal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
* History of herpetic keratitis.
* Pathological dry eye.
* Aphakia or amblyopia.
* History of refractive surgery, keratoconus or other corneal irregularity.
* Pregnancy, lactating or planning a pregnancy at the time of enrolment.
* Participation in any concurrent clinical trial or within the last 30 days.
20 Years
ALL
No
Sponsors
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HOYA Lamphun Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Graeme Young, Dr
Role: PRINCIPAL_INVESTIGATOR
Visioncare Research Ltd.
Central Contacts
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Other Identifiers
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HOYA-3601
Identifier Type: -
Identifier Source: org_study_id
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