Conditions: Dry Eye
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 183
Healthy volunteers: no

Brief summary:
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®

Detailed description:
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

Arms:
arm 1: PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution

doses: 1 drop in each eye, quarter in day arm 2: Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar

doses: 1 drop in each eye, quarter in day

Interventions: intervention 1: PRO-148 intervention 2: Systane
Intervention descriptions: intervention 1: Instill 1 drop in each eye four times a day, for 60 days intervention 2: Instill 1 drop in each eye four times a day, for 60 days

Protocol document: