UNICON silicone hydrogel daily disposable soft contact lenses — safety and performance

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.