Status:
COMPLETED
Clinical Evaluation of the Safety and Efficacy of Yung Sheng 38% Color Contact Lens
Lead Sponsor:
Yung Sheng Optical Co., Ltd.
Conditions:
Myopia
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
This was a single group, open-label clinical study to assess the safety and efficacy of Yung Sheng 38% color contact lens for vision correction.
Eligibility Criteria
Inclusion
- The subject must sign the informed consent form.
- The subject must be at least 20 years of age as of the date of evaluation for the study.
- The subject must have a spherical prescription range between 0 to -12.00 diopters in each eye.
- The subject must have manifest refraction Snellen visual acuities (VA) less than 0.8 in each naked eye.
- The subject must have normal eyes, except ametropia.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must appear able and willing to fill the daily card.
Exclusion
- The subjects who need to use ophthalmic medicine for therapy.
- The subjects who have ocular or systemic allergies or disease that may interfere with contact lens wear.
- The subjects who have any history of ocular surgery/injury within 8 weeks prior to enrollment.
- The subjects who have clinically significant tear secretion abnormal.
- The subjects who enrolled in another contact lens clinical trial within 30 days prior to enrolment.
Key Trial Info
Start Date :
June 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2014
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT06128473
Start Date
June 18 2013
End Date
July 3 2014
Last Update
November 13 2023
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