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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06128473
• Other study ID #: CE-120901
• Status: Completed
• Phase: N/A
• Start date: June 18, 2013
• Est. completion date: July 3, 2014

Study information

• Verified date: November 2023
• Source: Yung Sheng Optical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: July 3, 2014
• Est. primary completion date: July 3, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Soft Contact Lens
Vision Correction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yung Sheng Optical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety evaluation	Incidence of adverse events; Incidence of serious adverse events; The safety endpoint in this evaluation is the rate of serious adverse reactions related to visual acuity loss as well as accompanying slit-lamp findings and other associated observations.; [Time Frame: 12 weeks]	12 weeks
Primary	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	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
Secondary	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
Secondary	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