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OpenTrials
Completed

NCT Number: NCT06527586

A Study to Evaluate the Safety and Efficacy of Eye Secret UV Aspheric Silicone Soft (Hydrophilic) 1Day Color Contact Lens

This was a prospective, randomized, open label, parallel, active-controlled clinical study to assess the safety and efficacy of Silicone Color Contact Lens for vision correction.

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Key information

Age range

20 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital, Taipei, Taiwan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age from 20 to 65.
  • Subject with -1.00 to -10.00 D myopia, less than 1.00 D astigmatism.
  • Subjects must be correctable through spherocylindrical refraction and with soft contact lenses to 0 Log MAR (distance) or better in each eye.
  • Willing to comply with all study procedures and be available for the study duration.
  • Provide signed and dated informed consent form.

Exclusion criteria

  • Subjects have a history of allergies that contraindicate contact lens wear.
  • Subjects have other active ocular or systemic diseases such as, but not limited to anterior uveitis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermas, keratoconus or diabetes.
  • Subjects have medications that would contraindicate contact lens wear.
  • Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 months.
  • Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Any active participation in any contact lens or lens care product clinical trial within seven days prior to this study.
  • The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
  • Subject has a known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
  • Subject has a history of papillary conjunctivitis that has interfered with contact lens wear.
  • Subject has a history of herpetic keratitis retinal detachment or irregular cornea.
  • Subject has a history of recurrent eye or eyelid infections, adverse effects associated with your contact lens wear, intolerance or unusual response to your contact lens wear.
  • The subject has over grade II corneal and conjunctival staining (Oxford scheme) if who has a history of dry eye.
  • Subject had any corneal surgery (e.g., refractive surgery).

Treatment and study plan

Soft contact lens

Device

Vision Correction

Primary outcomes

  1. The effectiveness of corrected visual acuity

    Time frame: 3 Months

    The primary effectiveness endpoint of the study was the comparison of the mean change in logMAR visual acuity (VA) of the subject's worse eye, from baseline (Day 1) to the final visit (3-month), between the groups wearing test lenses and control lenses.

Secondary outcomes

  1. Effectiveness of corrected visual acuity

    Time frame: 1 Week

    The secondary effectiveness endpoint involves comparing the mean difference in LogMAR visual acuity (VA) for each eye-both eyes of each subject-between the test lens and the control lens at one week.

Sponsors and collaborators

Lead sponsor

Yung Sheng Optical Co., Ltd.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 30, 2024
Registry last updated
Jan 24, 2025

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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