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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Laboratorios Sophia S.A de C.V..
Recruitment status was  Active, not recruiting
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

February 20, 2012
February 29, 2012
September 2011
February 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01541891 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome
STUDY TO COMPARATIVE THE EFFICACY AND SAFETY OF PRO-148 OPHTHALMIC SOLUTION VS.SYSTANE® IN THE TREATMENT OF MILD-TO-MODERATE DRY 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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dry Eye Syndrome
  • Drug: PRO-148 Ophthalmic Solution
    PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 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.
  • Experimental: Arm A PRO 148 Ophthalmic Solution
    Intervention: Drug: PRO-148 Ophthalmic Solution
  • Active Comparator: Arm B. SYSTANE® Ophthalmic Solution
    Intervention: Drug: Active Comparator: SYSTANE ® Ophthalmic Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
Not Provided
February 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01541891
COXAVSSY0311FII, PRO-148
Yes
Laboratorios Sophia S.A de C.V.
Laboratorios Sophia S.A de C.V.
Not Provided
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
Laboratorios Sophia S.A de C.V.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP