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

Study Overview
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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.

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

Conditions
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Myopia

Intervention / Treatment
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* Device: Soft Contact Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yung Sheng 38% color contact lens<br> | Device: Soft Contact Lens<br>* Vision Correction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of corrected visual acuity | The visual acuity after contact lens correction should be more than or equal to 1.0 at the final visit for each subject. The percentage of successful contact lens correction of visual acuity should be more than 90 % among all subjects. | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens fitting (Lens position) | Lens position should be in the middle of eyes. The successful percentage among all subjects should be more than 80 %. Slit-lamp biomicroscopy will be assessed according to the approved study biomicroscopy CRF. | Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months | 
| Lens fitting (Lens movement) | Lens movement should be less than 1.5 mm. The successful percentage among all subjects should be more than 80 %. Slit-lamp biomicroscopy will be assessed according to the approved study biomicroscopy CRF. | Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months | 
| Lens fitting (Lens edge) | Lens edge should be normal after wearing. The successful percentage among all subjects should be more than 80 %. Slit-lamp biomicroscopy will be assessed according to the approved study biomicroscopy CRF. | Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months |