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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

Description

The purpose of this clinical study is to evaluate the safety and clinical performance of the investigational soft contact lens when worn in a daily wear modality, by assessing total suspended eye(s) as the primary variable.

Eligibility

Inclusion Criteria:

  1. Adult with an age ≥ 18;
  2. Be a currently adapted soft contact lens wearer who successful wear of soft contact lenses in both eyes for a minimum of 5 days per week and 6 hours per day within 3 months prior to study screening (by verbal confirmation);
  3. Participant must be stop wearing any contact lenses more than 7 days prior to screening;
  4. Able to wear contact lenses within a range of power from -2.00D to -6.00D (0.25 D steps) in both eyes;
  5. Astigmatism of 1.25D or less in both eyes;
  6. Be correctable to a visual acuity of 1.0 decimal (0.0 logMAR) or better in each eye;
  7. Participant must be able to be successfully fit with study lenses;
  8. The participant must appear able and willing to adhere to the instructions set forth in this clinical protocol;
  9. The participant must read and sign the Informed Consent Form.

Exclusion Criteria:

  1. Women who are currently pregnant;
  2. Women who are lactating or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit);
  3. Any use of systemic or ocular medications (e.g., non-steroidal anti-inflammatory eye drops, ophthalmic steroids) within 30 days prior to study enrollment for which contact lens wear could be contraindicated, as determined by the investigator;
  4. Any current or history ocular or systemic disease which may interfere with contact lens wear, as determined by the investigator;
  5. Any current or previous orthokeratology treatment within 90 days prior to study enrollment, or planned for orthokeratology treatment during the study;
  6. Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.) or planned for ocular and/or refractive surgery during the study;
  7. Current or history of herpetic keratitis in either eye;
  8. Current or history of intolerance, hypersensitivity or allergy to silicone hydrogel soft contact lenses or any component of the study products;
  9. Current clinical finding of entropion, ectropion, chalazia, recurrent styes, glaucoma, pathologically dry eye (defined as Schirmer test \< 5 mm/5 min), recurrent corneal erosions, aphakia, or moderate or above corneal distortion;
  10. Employee of Department of Ophthalmology and clinic (e.g., Investigator, Coordinator, Technician);
  11. Participation in any interventional clinical trial within 30 days prior to study enrollment;
  12. Any biomicroscopy findings at screening that are Grade 3 or higher and/or corneal neovascularization that is Grade 2 or higher and/or presence of corneal infiltrates;
  13. Any history of a contact lens-related corneal inflammatory or infectious event within 12 months prior to study enrollment that may contraindicate contact lens wear;
  14. Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
  15. Participants are considered ineligible for the study as judged by the investigator.

Study details
    Refractive Ametropia

NCT07322211

Unicon Optical Co. Ltd.

1 February 2026

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FAQs

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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