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

NCT06128486 | Completed DMC

• 1 other identifier: CE-120410
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Lens fitting (Lens position)

  Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months

• Lens fitting (Lens movement)

  Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months

• Lens fitting (Lens edge)

  Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months

Other Outcomes (1)

• Safety evaluation

  12 weeks

Study Arms (1)

Yung Sheng 55% Color Contact Lens

EXPERIMENTAL

Device: Soft Contact Lens

Interventions

Soft Contact Lens DEVICE

Vision Correction

Yung Sheng 55% Color Contact Lens

Eligibility Criteria

• Age: 20 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yung Sheng Optical Co., Ltd.: lead

MeSH Terms

Conditions

Myopia

Interventions

Contact Lenses, Hydrophilic

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Contact Lenses; Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Huey-Chuan Cheng, MD / MS

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Ming-Cheng TAI, MD

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: August 25, 2012
• Primary Completion: March 17, 2014
• Study Completion: March 17, 2014
• Last Updated: November 13, 2023

Record last verified: 2023-11