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OpenTrials
Completed

NCT Number: NCT06128486

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Soft contact lens

Device

Vision Correction

Primary outcomes

  1. The effectiveness of corrected visual acuity

    Time frame: 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

  1. Lens fitting (Lens position)

    Time frame: 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.

  2. Lens fitting (Lens movement)

    Time frame: 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.

  3. Lens fitting (Lens edge)

    Time frame: 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

  1. Safety evaluation

    Time frame: 12 weeks

    • 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.

Sponsors and collaborators

Lead sponsor

Yung Sheng Optical Co., Ltd.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 13, 2023
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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