Evaluation of Blink Tears and Systane Concomitant With Restasis for the Treatment of Dry Eye Symptoms

Dry eye is a chronic condition that is believed to afflict more than 3 million patients in
the United States.1 Symptoms of dry eye are very bothersome and impact quality of life,
reduce work capacity, and may result in poorer psychological health. Also, symptoms of dry
eye are associated with a decreased ability to perform activities that require visual
attention such as reading and driving a car.2 Patients with dry eye complain most frequently
of a scratchy or sandy (foreign body) sensation. Other common symptoms are itching, excessive
mucus secretion, inability to produce tears, a burning sensation, photosensitivity, redness,
pain, and difficulty in moving the lids. In most patients, the most remarkable feature of the
eye examination is the grossly normal appearance of the eye.3 Chronic dry eye disease is
associated with an inflammatory mechanism mediated by activated T-cell lymphocytes3 which
affects the ocular surface and lacrimal gland.4 The damage caused by dry eye disease may be
irreversible, and despite the availability of various tear substitutes, many patients with
dry eye syndrome experience corneal injuries with a subsequent reduction in vision.5
Cyclosporin A (Restasis®, Allergan, Irvine, CA) has been shown to significantly reduce the
number of activated T-lymphocytes within the conjunctiva6, thereby minimizing the
inflammation causing dry eye. Topical cyclosporin A 0.05% ophthalmic emulsion (Restasis®,
Allergan, Irvine, CA) increases tear production and improves the quality of naturally
produced tears and is the first approved therapeutic agent for the treatment of chronic dry
eye and the only treatment modality that addresses the underlying pathology.

In addition to topical therapy with cyclosporine, some patients continue to use artificial
tears for occasional relief of residual symptoms. The choice of concomitant tear is important
but little research has been published differentiating between the efficacy of these
solutions when used concomitantly with topical cyclosporine.

Inclusion Criteria:

1. Subject must have dry eye.

2. Age: 18 years and older.

3. Males or females

4. Up to grade 3 conjunctival staining.

5. Score of no more than 4 on the Subjective Evaluation of Symptoms of Dryness (SESOD) at
screening.

6. Currently using Restasis to treat dry eye syndrome (at least for 3 months prior to
enrollment).

7. Willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:

1. Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least
3 months without improvement.

2. Known contraindications to any study medication or ingredients.

3. Planned use of contact lenses (unless discontinued use more than 30 days prior to
randomization.

4. Contact lens use during the active treatment portion of the trial.

5. Active ocular allergies.

6. Ocular surgery within the past 3 months.

7. Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.

8. Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are
actively being treated or disease that is uncontrollable.

9. Pregnant or nursing mothers and females of childbearing potential not practicing a
reliable and medically acceptable method of birth control.

10. Participation in (or current participation) any investigational drug or device trial.

11. Conjuctival staining grade 4.