Dry Eye Clinical Trial
Official title:
A Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye
The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with ophthalmic solution Systane®
Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms
of discomfort, visual disturbance, and tear film instability with potential damage to the
ocular surface. Current treatment is heavily weighted toward supplementation, stimulation, or
preservation of aqueous tears. Artificial tears are one of the primary treatments for dry
eye; it is mainly palliative and focuses on reducing the symptoms of discomfort to improve
quality of life for a patient.
A phase III randomized double-blind clinical trial will be conducted to evaluate efficacy and
safety of the ophthalmic solution PRO-148 in the ocular surface of patients with mild to
moderate dry eye compared with ophthalmic solution Systane®. Patients will be randomized to
receive one of the treatments for 60 days. Efficacy and safety measures will be performed at
baseline and at 60 days after treatment
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