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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Soft Contact Lens

• Registration Number: NCT06128473
• Lead Sponsor: Yung Sheng Optical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-18
• Primary Completion: 2014-07-03
• Study Completion: 2014-07-03
• Status Verified: 2023-11
• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-07
• Last Update Submitted: 2023-11-07
• Study First Posted: 2023-11-13
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Yung Sheng 38% color contact lens	Soft Contact Lens	-

Primary Outcome Measures

Name	Time	Method
The effectiveness of corrected visual acuity	3 Months	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.

Secondary Outcome Measures

Name	Time	Method
Lens fitting (Lens edge)	Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months	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.
Lens fitting (Lens position)	Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months	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.
Lens fitting (Lens movement)	Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months	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.