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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fase II Comparative Study of the Efficacy and Safety of PRO-148 Ophthalmic Solution vs Systane in the Treatment of Mild-to-moderate Eye Syndrome.

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: PRO-148 Ophthalmic Solution
* Drug: Active Comparator: SYSTANE ® Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with diagnosis of mild-to-moderate drye eye syndrome. Male or female patients. Patients 18 years of age 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRO-148 Ophthalmic Solution<br>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 | Drug: PRO-148 Ophthalmic Solution<br>* PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.<br>* Other names: PRO-148;|
| Active Comparator: Arm B. SYSTANE® Ophthalmic Solution<br>Drug: SYSTANE® Intervention name: SYSTANE® applied in ocular surface of patients with mild to moderate dry eye syndrome q.i.d. for 60 days | Drug: Active Comparator: SYSTANE ® Ophthalmic Solution<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Film Break-up Time (TBUT) | TBUT was evaluated at baseline and end of the study | During 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Adverse Events | The presence of adverse events will be reported in both treatment arms. This variable will be reported by the number of events presented. | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRO-148, Dry eye syndrome