Actively Recruiting

Phase Not Applicable
Age: 18Days +
All Genders
NCT07322211

A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses

Led by Unicon Optical Co. Ltd. · Updated on 2026-01-22

35

Participants Needed

2

Research Sites

40 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

13 weeks, open-label, daily disposable contact lens dispensing study.

CONDITIONS

Official Title

A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses

Who Can Participate

Age: 18Days +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult aged 18 years or older
  • Currently wearing soft contact lenses successfully on both eyes at least 5 days per week and 6 hours per day within 3 months before screening
  • Stopped wearing any contact lenses more than 7 days before screening
  • Can wear contact lenses with power between -2.00D to -6.00D (in 0.25 D steps) in both eyes
  • Astigmatism of 1.25D or less in both eyes
  • Correctable to a visual acuity of 1.0 decimal (0.0 logMAR) or better in each eye
  • Able to be successfully fitted with study lenses
  • Willing and able to follow study instructions
  • Able to read and sign the Informed Consent Form
Not Eligible

You will not qualify if you...

  • Currently pregnant women
  • Women who are lactating or planning pregnancy at enrollment
  • Use of systemic or ocular medications within 30 days before enrollment that contraindicate contact lens wear
  • Any current or past ocular or systemic disease interfering with contact lens wear
  • Orthokeratology treatment within 90 days before enrollment or planned during study
  • History or planned ocular/refractive surgery
  • Current or past herpetic keratitis in either eye
  • Intolerance, allergy, or hypersensitivity to silicone hydrogel lenses or their components
  • Clinical findings such as entropion, ectropion, chalazia, recurrent styes, glaucoma, pathological dry eye, recurrent corneal erosions, aphakia, or moderate or higher corneal distortion
  • Employees of the ophthalmology department or clinic involved in the study
  • Participation in any interventional clinical trial within 30 days before enrollment
  • Biomicroscopy findings of Grade 3 or higher or corneal neovascularization Grade 2 or higher or corneal infiltrates
  • History of contact lens-related corneal inflammatory or infectious event within 12 months before enrollment
  • Anterior segment infection, inflammation, abnormality, or disease contraindicating contact lens wear
  • Any participant deemed ineligible by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 807

Actively Recruiting

2

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan, 333

Actively Recruiting

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Research Team

N

Nick Liao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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