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Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye

This study is not yet open for participant recruitment.
Verified August 2012 by Laboratorios Sophia S.A de C.V.
Sponsor:
Information provided by (Responsible Party):
Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier:
NCT01657253
First received: July 19, 2012
Last updated: August 3, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with ophthalmic solution Systane®


Condition Intervention Phase
Dry Eye
 Drug: PRO-148
Drug: Systane
 Phase 3

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: A Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye

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:
  • Tear film break up time [ Time Frame: Day 60 ] [ Designated as safety issue: No ]
    Change from Baseline in Tear film break up time after 60 days of treatment

  • Ocular Surface Disease Index [ Time Frame: Day 60 ] [ Designated as safety issue: No ]
    Change from Baseline in Ocular Surface Disease Index after 60 days of treatment


Secondary Outcome Measures:
  • Schirmer test [ Time Frame: Day 60 ] [ Designated as safety issue: No ]
    Change from Baseline in Schirmer test after 60 days of treatment


Estimated Enrollment: 300
Study Start Date: November 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRO-148 Drug: PRO-148
Instill one drop in each eye four times a day (QID), for 60 days
Other Name: PRO-148
Active Comparator: Systane®
Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar
 Drug: Systane
Instill one drop in each eye four times a day (QID), for 60 days
Other Name: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar

Detailed Description:

Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. Current treatment is heavily weighted toward supplementation, stimulation, or preservation of aqueous tears. Artificial tears are one of the primary treatments for dry eye; it is mainly palliative and focuses on reducing the symptoms of discomfort to improve quality of life for a patient.

A phase III randomized double-blind clinical trial will be conducted to evaluate efficacy and safety of the ophthalmic solution PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with ophthalmic solution Systane®. Patients will be randomized to receive one of the treatments for 60 days. Efficacy and safety measures will be performed at baseline and at 60 days after treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild to moderate dry eye patients based on the Report of International Dry Eye Workshop (DEWS)
  • OSDI score between 12 and 45
  • Provided informed consent

Exclusion Criteria:

  • Patients with one blind eye
  • Visual acuity of 20/100 or worst in any eye
  • Patients with any active ocular disease that would interfere with study interpretation
  • Patients in treatment with any medication that could interfere with the study, contraindication of any medication used in the protocol
  • Patients with history of hypersensitivity or contraindication for any drug used in the study
  • Contact lens users
  • Pregnant patients, at risk of pregnancy or breastfeeding
  • Patients without birth control treatment
  • Patients who had participated in any clinical trial in the last 90 days
  • Legal or mentally disabled patients who could not give informed consent
  • Patients who do not provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657253

Contacts
Contact: Leopoldo M Baiza-Durán, MD +52(33) 30014200 ext 1051 lbaiza@sophia.com.mx
Contact: Clotilde Ayala-Barajas, MSc +52(33) 30014200 ext 1074 clotilde.ayala@sophia.com.mx

Sponsors and Collaborators
Laboratorios Sophia S.A de C.V.
  More Information

No publications provided

Responsible Party: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier: NCT01657253     History of Changes
Other Study ID Numbers: SOPH148-0512/III
Study First Received: July 19, 2012
Last Updated: August 3, 2012
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

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

ClinicalTrials.gov processed this record on May 23, 2013