Clinical Biocompatibility Evaluation of Contact Lens Coatings

Clinical Biocompatibility Evaluation of Contact Lens Coatings

The primary objective is to evaluate corneal staining observed after 2 hours of wear with contact lenses with investigational coating against PureVision™ lenses, all pre-cycled with OPTI-FREE® RepleniSH® multi-purpose disinfection solution.

In this contralateral crossover study, qualifying subjects will wear a total of 2 pairs of study contact lenses. Lenses will be worn according to a randomized lens sequence assignment. Each pair will consist of a test lens (Test 1 or Test 2) and a control lens.

Inclusion Criteria:

• Able to understand and must sign an Informed Consent;
• Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
• Manifest cylinder less than or equal to 1.50 diopter (D) in each eye;
• Best Corrected Visual Acuity (BCVA) 20/25 or better in each eye;
• VA with habitual spectacles 20/40 in both eyes (OU) or better and willing to wear spectacles as needed during the washout period and during study lens exposure;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
• History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye;
• Ocular or intra-ocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
• Current or history of pathologically dry eye in either eye that would preclude contact lens wear;
• Current or history of herpetic keratitis in either eye;
• Eye injury in either eye within 12 weeks immediately prior to enrollment;
• History of intolerance or hypersensitivity to any component of the study lenses or solutions;
• Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
• Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
• Other protocol-specified exclusion criteria may apply.