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

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.

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Drug: PRO-148 Ophthalmic Solution; Drug: Active Comparator: SYSTANE ® Ophthalmic Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: PRO-148 Ophthalmic Solution; PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.; Other Names: PRO-148
Active Comparator: 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	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Visual Acuity	The LogMAR scale evaluates the visual acuity of subjects with a logarithmic scale where base 0 is the best visual acuity and 1 is the worst. This variable will be reported with means for comparison between groups.	60 days

Collaborators and Investigators

• Sponsor: Laboratorios Sophia S.A de C.V.
• Investigators: Principal Investigator: José F Alaniz-De La O, MD, Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"; Principal Investigator: Laura R Saucedo-Rodíguez, MD, Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"; Study Director: Leopoldo M Baiza-Durán, MD, Clinical Research Department. Laboratorios Sophia SA de CV

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: February 20, 2012
• First Submitted That Met QC Criteria: February 29, 2012
• First Posted (Estimate): March 1, 2012

Study Record Updates

• Last Update Posted (Actual): October 30, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Dry eye syndrome; PRO-148
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: COXAVSSY0311FII; PRO-148 (Other Identifier: SOPHIA PRO-148)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No