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

RecruitingNAAges 18 Days - anyAllUnicon Optical Co. Ltd.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Adult with an age โ‰ฅ 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.
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What it tests

  • Treatment
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Where

2 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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