ESBA105 in Patients With Severe Dry Eye

Evaluation of ESBA105 in the Persistent Relief of Ocular Discomfort in Patients With Severe Dry Eye

The purpose of this study was to evaluate the efficacy of ESBA105 over vehicle in reducing the ocular symptoms of dry eye disease, as measured by a mean global Visual Analog Scale (VAS) discomfort score.

Following Run-In, patients qualifying for treatment were randomized 2:1 to receive ESBA105 (experimental group) or Vehicle (control group) for 4 weeks. Patients not qualifying for treatment (based on global VAS discomfort score), were discontinued from the study.

Inclusion Criteria:

• Ongoing physician diagnosis of dry eye for at least 6 months.
• Use of artificial tears, gels, lubricants, or re-wetting drops on a regular basis.
• Experience persistent ocular discomfort.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Contact lens wearers.
• Severe Sjogren's Syndrome.
• History of corneal surgery including refractive surgeries.
• Intraocular surgery within 6 months of Visit 1.
• Intraocular or periocular injection within 6 months of Visit 1.
• Lid function abnormalities.
• Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1.
• Any acute infectious or non-infectious ocular condition of the anterior or posterior segments in either eye within 30 days of Visit 1.
• Diseases/conditions of ocular surface associated with clinically significant scarring/destruction of conjunctiva/cornea.
• Other protocol-defined exclusion criteria may apply.