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

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
PRO-148 Ophthalmic Solution
Active Comparator: SYSTANE ® Ophthalmic Solution
Sponsored by
Laboratorios Sophia S.A de C.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring PRO-148, Dry eye syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRO-148 Ophthalmic Solution

Arm B. SYSTANE® Ophthalmic Solution

Arm 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

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

Outcomes

Primary Outcome Measures

Tear Film Break-up Time (TBUT)
TBUT was evaluated at baseline and end of the study

Secondary Outcome Measures

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.

Full Information

First Posted
February 20, 2012
Last Updated
February 8, 2018
Sponsor
Laboratorios Sophia S.A de C.V.
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1. Study Identification

Unique Protocol Identification Number
NCT01541891
Brief Title
Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome
Acronym
PRO-148
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Sophia S.A de C.V.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
PRO-148, Dry eye syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRO-148 Ophthalmic Solution
Arm Type
Experimental
Arm 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
Arm Title
Arm B. SYSTANE® Ophthalmic Solution
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
PRO-148 Ophthalmic Solution
Other Intervention Name(s)
PRO-148
Intervention Description
PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.
Intervention Type
Drug
Intervention Name(s)
Active Comparator: SYSTANE ® Ophthalmic Solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tear Film Break-up Time (TBUT)
Description
TBUT was evaluated at baseline and end of the study
Time Frame
During 60 days
Secondary Outcome Measure Information:
Title
Presence of Adverse Events
Description
The presence of adverse events will be reported in both treatment arms. This variable will be reported by the number of events presented.
Time Frame
60 days
Other Pre-specified Outcome Measures:
Title
Evaluation of Visual Acuity
Description
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.
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José F Alaniz-De La O, MD
Organizational Affiliation
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura R Saucedo-Rodíguez, MD
Organizational Affiliation
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leopoldo M Baiza-Durán, MD
Organizational Affiliation
Clinical Research Department. Laboratorios Sophia SA de CV
Official's Role
Study Director
Facility Information:
Facility Name
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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