Clinical Evaluation of the Safety and Efficacy of Yung Sheng 55 % Color Contact Lens

NCT06128486 — Not applicable, Completed, 62 participants, Yung Sheng Optical Co., Ltd.

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Registry	NCT06128486
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	62 (Actual)
Sponsor	Yung Sheng Optical Co., Ltd. (Industry)
Conditions	Myopia
Interventions	Soft Contact Lens (Device)
Dates	start 2012-08-25, primary completion 2014-03-17, completion 2014-03-17, first posted 2023-11-13, last updated 2023-11-13

-Summary

This was a single group, open-label clinical study to assess the safety and efficacy of Yung Sheng 55% Color Contact Lens for vision correction.

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+Arms and interventions

Arm	Type	Interventions	Description
Yung Sheng 55% Color Contact Lens	Experimental	Device: Soft Contact Lens

Soft Contact Lens (Device): Vision Correction

+Outcome measures

Primary outcomes

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 outcomes

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.
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.

Other outcomes

Safety evaluation [12 weeks]: 1. Incidence of adverse events; 2. 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.

+Eligibility

Sex: All, ages: 20 Years to any

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.

+Investigators

Huey-Chuan Cheng, MD / MS, Principal investigator, Mackay Memorial Hospital
Ming-Cheng TAI, MD, Principal investigator, Tri-Service General Hospital (TSGH)