Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Patients with one blind eye.
Visual acuity of 20/40 in any eye
Patients with history of active stage of any other concomitant ocular disease.
Patients taking any medication, topically or by any other route, which could interfere with the study's results, in the 3 days prior to trial or until a time period in which residual effects could be present.
Contraindications or sensitivity to any component of the study treatments.
Ocular surgery within the past 3 months.
Contact lens users.
Females of childbearing potential )may not participate in the study if any of the following conditions exist:
- They are pregnant,
- They are breastfeeding,
- They have a positive urine pregnancy test at screening,
- They intend to become pregnant during the study, or
- They do not agree to use adequate birth control methods for the duration of the study.
Participation in any studies of investigational drugs within 90 days previous to the inclusion.

Discontinuation criteria:

Patients could be discontinued before the completion of the study because of adverse events, pregnancy, protocol violations, lack of efficacy, or administrative reasons.

Arm && Interventions

Group	Intervention	Description
PRO-148 Ophthalmic Solution	PRO-148 Ophthalmic Solution	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

Primary Outcome Measures

Name	Time	Method
Tear Film Break-up Time (TBUT)	During 60 days	TBUT was evaluated at baseline and end of the study

Secondary Outcome Measures

Name	Time	Method
Presence of Adverse Events	60 days	The presence of adverse events will be reported in both treatment arms. This variable will be reported by the number of events presented.