TearLab Refractive Surgery Dry Eye Study

Dry eye disease is a common and major source of disability, whether occurring as a primary
disorder or as a component of other diseases and its onset may be triggered or modified by
exposure to systemic drugs, contact lens wear, ocular surgery and adverse environmental and
work conditions. The development of a reliable, highly sensitive and specific test for the
clinical diagnosis of dry eye is a major unmet clinical need, particularly to differentiate
it from common conditions such as ocular allergy which exhibit similar presenting symptoms.
Tear hyper-osmolarity is central to the dry eye disease process and the measurement of tear
osmolarity could serve not only as a highly accurate diagnostic test but also as a measure
of disease severity and a means to monitor treatment efficacy.

Recently, there have been reports in the literature regarding dry eye disease; both early
and chronic following refractive surgery, with many cases potentially being previously
inadvertently undiagnosed dry eye disease.

Inclusion Criteria:

- Male or female, twenty-one years of age or older.

- Confirmed diagnosis of refractive error receiving LASIK surgery.

- Patient motivation and willingness to cooperate with the investigator and ability to
return for all visits during the study.

Exclusion Criteria:

- Compromised cognitive ability that may be expected to interfere with study
compliance.

- Clinically significant eyelid deformity or eyelid movement disorder that is caused by
conditions such as notch deformity, incomplete lid closure, entropion, ectropion,
hordeola or chalazia.

- Previous ocular disease leaving sequelae or requiring current topical eye therapy
other than for DED, including, but not limited to: active corneal or conjunctival
infection of the eye and ocular surface scarring.

- Active ocular allergy

- Patients requiring punctual occlusion prior to surgery

- Patients requiring cyclosporine ophthalmic emulsion prior to surgery

- Standard exclusion criteria for refractive surgery used by each surgeon.

- Known hypersensitivity to any of the agents used in testing

- Ophthalmologic drop use within 2 hours of any visit