Clinical Evaluation of the Safety and Efficacy of Yung Sheng 38% Color Contact Lens

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-18

Study Completion Date

2014-07-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Yung Sheng 38% color contact lens

Group Type EXPERIMENTAL

Soft Contact Lens

Intervention Type DEVICE

Vision Correction

Interventions

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Soft Contact Lens

Vision Correction

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. The subject must sign the informed consent form.
2. The subject must be at least 20 years of age as of the date of evaluation for the study.
3. The subject must have a spherical prescription range between 0 to -12.00 diopters in each eye.
4. The subject must have manifest refraction Snellen visual acuities (VA) less than 0.8 in each naked eye.
5. The subject must have normal eyes, except ametropia.
6. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
7. The subject must appear able and willing to fill the daily card.

Exclusion Criteria

1. The subjects who need to use ophthalmic medicine for therapy.
2. The subjects who have ocular or systemic allergies or disease that may interfere with contact lens wear.
3. The subjects who have any history of ocular surgery/injury within 8 weeks prior to enrollment.
4. The subjects who have clinically significant tear secretion abnormal.
5. The subjects who enrolled in another contact lens clinical trial within 30 days prior to enrolment.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No