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

Laboratorios Sophia

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndrome

Treatments: Drug: PRO-148 Ophthalmic Solution; Drug: Active Comparator: SYSTANE ® Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01541891

PRO-148 (Other Identifier)

COXAVSSY0311FII

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

PRO-148 Ophthalmic Solution

Experimental group

Description:

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

Treatment:

Drug: PRO-148 Ophthalmic Solution

Arm B. SYSTANE® Ophthalmic Solution

Active Comparator group

Description:

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

Treatment:

Drug: Active Comparator: SYSTANE ® Ophthalmic Solution