An Investigation of the Impact of Localized Topical Anesthesia of the Ocular Surface on End-of-day Contact Lens Discomfort

Inclusion criteria

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:

• They are of legal age (18 years) and capacity of volunteer.
• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• They must appear able and willing to adhere to the instructions set forth in this clinical protocol.
• They have worn the same brand of soft spherical contact lenses for at least the previous three months, by self-report.
• They are defined as 'symptomatic' contact lens wearers (CLDEQ-8 score of 20-37) with their habitual contact lenses.
• They are willing to wear their lenses for approximately 14 hours on study days.
• They have a wearable pair of spectacles, if applicable.
• They agree not to participate in other clinical research for the duration of this study.
• They can attain high contrast logMAR visual acuity of 0.20 or better in their habitual contact lenses in each eye.

Exclusion criteria

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:

• They have an ocular disorder, which would normally contra-indicate contact lens wear.
• They have a systemic disorder, which would normally contra-indicate contact lens wear.
• They are using any topical medication such as eye drops or ointment.
• They have had cataract or corneal refractive surgery.
• They are pregnant or breast-feeding by self-report.
• They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV), by self-report.
• They have any known hypersensitivity or allergic reaction to any of the known ingredients in the anesthetic.
• They have a history of severe allergic reaction or anaphylaxis.
• They have a history of cardiac disease or hyperthyroidism.
• They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
• They are an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
• They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
• They have grade 3 or greater of any of the following ocular surface signs which would contraindicate contact lens wear: corneal edema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.