Conditions: Dry Eye Syndrome
Keywords: PRO-148 Dry eye syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.

Detailed description:
A phase 2, randomized, double masked clinical, parallel-group clinical trial to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.

Arms:
arm 1: Drug: PRO-148 Intervention name: PRO-148 applied in ocular surface of patients with mild to moderate dry eye syndrome q.i.d. for 60 days arm 2: Drug: SYSTANE® Intervention name: SYSTANE® applied in ocular surface of patients with mild to moderate dry eye syndrome q.i.d. for 60 days

Interventions: intervention 1: PRO-148 Ophthalmic Solution intervention 2: Active Comparator: SYSTANE ® Ophthalmic Solution
Intervention descriptions: intervention 1: PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days. intervention 2: Sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium chloride, zinc chloride and polyquad (polidronium chloride) 0,001%. four times per day (c/6 hours) during 60 days.

Protocol document: