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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Soft Contact Lens

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yung Sheng 55% Color Contact Lens	Device: Soft Contact Lens; Vision Correction

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Collaborators and Investigators

• Sponsor: Yung Sheng Optical Co., Ltd.
• Investigators: Principal Investigator: Ming-Cheng TAI, MD, Tri-Service General Hospital; Principal Investigator: Huey-Chuan Cheng, MD / MS, Mackay Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2012
• Primary Completion (Actual): March 17, 2014
• Study Completion (Actual): March 17, 2014

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Estimated): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CE-120410

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No