Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens
NCT ID: NCT04299243
Last Updated: 2020-03-06
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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COMPLETED
NA
148 participants
INTERVENTIONAL
2018-11-25
2019-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Spherical Lens
Randomized to Spherical Lens worn in a daily disposable mode
Contact Lenses
Contact lenses for vision correction
SiHy Daily
Randomized to SiHy Daily worn in a daily disposable mode
Contact Lenses
Contact lenses for vision correction
Interventions
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Contact Lenses
Contact lenses for vision correction
Eligibility Criteria
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Inclusion Criteria
* Spherical power: -0.25 to -10.00D
* Cylinder power ≤0.75D and Sph.P:Cyl.P≥3:1, or 1.00D≤ cylinder power ≤1.50D and Sph.P:Cyl.P ≥4:1;
* Both eyes are ametropia, and there is no case where the investigator believes that the soft contact lens cannot be worn;
: The case of wearing a soft contact lens as referred to in this trial is: i) No eyelid abnormalities or infections; ii) No clinically significant slit lamp findings iii) No other active eye diseases.
* BCVA of the left and right eye subjective refraction is greater than or equal to 5.0.
Exclusion Criteria
* Dry eye syndrome
* Any systemic disease contraindications to contact lenses or disease medications can affect the wearing of contact lenses
* Wearing a hard contact lens in the past 6 weeks
* Tear film break-up time is less than or equal to 5s
* Allergic to contact lenses and/or contact lenses
* Keratoconus or other irregular corneal patients
* Soft hydrophilic contact lens wearers are affected by long-term special conditions such as dryness, severe dust or volatile chemicals
* Pregnant, lactating or plan to be pregnant
* Only one eye meets the requirements for enrollment
* Participating in other clinical trials or less than ten days after the end of a soft contact lens clinical trial
* Less than three months after the end of a drug clinical trial
* Determined by the investigator that could not be enrolled
18 Years
45 Years
ALL
Yes
Sponsors
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Menicon Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Li Lihua, MD
Role: PRINCIPAL_INVESTIGATOR
Tianjin Eye Hospital
Locations
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Tianjin Eye Hospital
Tianjin, , China
Countries
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Other Identifiers
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SLP-01
Identifier Type: -
Identifier Source: org_study_id
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