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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier:
NCT01541891
First received: February 20, 2012
Last updated: February 29, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Dry Eye Syndrome
 Drug: PRO-148 Ophthalmic Solution
Drug: Active Comparator: SYSTANE ® Ophthalmic Solution
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: STUDY TO COMPARATIVE THE EFFICACY AND SAFETY OF PRO-148 OPHTHALMIC SOLUTION VS.SYSTANE® IN THE TREATMENT OF MILD-TO-MODERATE DRY EYE SYNDROME

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Laboratorios Sophia S.A de C.V.:

Primary Outcome Measures:
  • Efficacy outcomes measures. [ Time Frame: During 60 days ] [ Designated as safety issue: No ]
    • Evaluating of ocular signs, corneal and interpalpebral conjunctival staining ( Fluoroscein and lissamine green staining), schirmer tear test, tear break-up time and ocular surface condition.
    • Evaluating of symptom of dry eye, OSDI and investigator's evaluation of global response to treatment.


Secondary Outcome Measures:
  • Safety outcomes measures. [ Time Frame: During 60 days ] [ Designated as safety issue: Yes ]
    • Evaluation of ocular symptoms and signs,visual acuity (VA), biomicroscopy, intraocular pressure (IOP), funduscopy and cup disc-ratio.
    • Frequency, severity and relationship to study medication of all adverse events occurring during the course of the study.


Enrollment: 30
Study Start Date: September 2011
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A PRO 148 Ophthalmic Solution Drug: PRO-148 Ophthalmic Solution
PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.
Active Comparator: Arm B. SYSTANE® Ophthalmic Solution 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541891

Locations
Mexico
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, Mexico, 44280
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier: NCT01541891     History of Changes
Other Study ID Numbers: COXAVSSY0311FII, PRO-148
Study First Received: February 20, 2012
Last Updated: February 29, 2012
Health Authority: Mexico: Mexican Regulatory Agency, Mexico's Health Ministry

Keywords provided by Laboratorios Sophia S.A de C.V.:
PRO-148
Dry eye syndrome

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on May 22, 2013