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

NCT ID: NCT01541891

Last Updated: 2018-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-05-31

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.

Conditions

Dry Eye Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

PRO-148 Ophthalmic Solution

Intervention Type: DRUG

PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.

Arm B. SYSTANE® Ophthalmic Solution

Drug: SYSTANE® Intervention name: SYSTANE® applied in ocular surface of patients with mild to moderate dry eye syndrome q.i.d. for 60 days

Group Type: ACTIVE_COMPARATOR

Active Comparator: SYSTANE ® Ophthalmic Solution

Intervention Type: DRUG

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.

Interventions

PRO-148 Ophthalmic Solution

PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.

Intervention Type: DRUG

Active Comparator: SYSTANE ® Ophthalmic Solution

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.

Intervention Type: DRUG

Other Intervention Names

PRO-148

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratorios Sophia S.A de C.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José F Alaniz-De La O, MD

Role: PRINCIPAL_INVESTIGATOR

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Laura R Saucedo-Rodíguez, MD

Role: PRINCIPAL_INVESTIGATOR

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Leopoldo M Baiza-Durán, MD

Role: STUDY_DIRECTOR

Clinical Research Department. Laboratorios Sophia SA de CV

Locations

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Jalisco, Mexico

Countries

Mexico

Other Identifiers

PRO-148

Identifier Type: OTHER

Identifier Source: secondary_id

COXAVSSY0311FII

Identifier Type: -

Identifier Source: org_study_id