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:
- Adult with an age ≥ 18;
- 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);
- Participant must be stop wearing any contact lenses more than 7 days prior to screening;
- Able to wear contact lenses within a range of power from -2.00D to -6.00D (0.25 D steps) in both eyes;
- Astigmatism of 1.25D or less in both eyes;
- Be correctable to a visual acuity of 1.0 decimal (0.0 logMAR) or better in each eye;
- Participant must be able to be successfully fit with study lenses;
- The participant must appear able and willing to adhere to the instructions set forth in this clinical protocol;
- The participant must read and sign the Informed Consent Form.
Exclusion Criteria:
- Women who are currently pregnant;
- Women who are lactating or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit);
- 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;
- Any current or history ocular or systemic disease which may interfere with contact lens wear, as determined by the investigator;
- Any current or previous orthokeratology treatment within 90 days prior to study enrollment, or planned for orthokeratology treatment during the study;
- 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;
- Current or history of herpetic keratitis in either eye;
- Current or history of intolerance, hypersensitivity or allergy to silicone hydrogel soft contact lenses or any component of the study products;
- 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;
- Employee of Department of Ophthalmology and clinic (e.g., Investigator, Coordinator, Technician);
- Participation in any interventional clinical trial within 30 days prior to study enrollment;
- 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;
- 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;
- Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
- Participants are considered ineligible for the study as judged by the investigator.