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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01657253
Recruitment Status : Completed
First Posted : August 6, 2012
Results First Posted : December 15, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Dry Eye Drug: PRO-148 Drug: Systane Phase 3

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


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2013
Primary Completion Date : February 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
Drug Information available for: Systane
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: PRO-148

PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution

doses: 1 drop in each eye, quarter in day

Drug: PRO-148
Instill 1 drop in each eye four times a day, for 60 days
Other Name: PRO-148 (xanthan gum and sulphate chondroitin)
Active Comparator: Systane®

Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar

doses: 1 drop in each eye, quarter in day

Drug: Systane
Instill 1 drop in each eye four times a day, for 60 days
Other Name: polyethyleneglycol 400, propyleneglycol, hydroxypropyl guar


Outcome Measures

Primary Outcome Measures :
  1. Ocular Surface Disease Index (OSDI©) Questionnaire [ Time Frame: Day 60 ]
    Ocular Surface Disease Index (OSDI©) questionnaire , consists of 12 questions divided in 3 groups, Each question has a value that can go from 0 to 4 points according to the severity of the case: 0.None of the time, 1. Some of the time, 2.Half of the time, 3.most of the time and 4 all of the time. The points of all the questions will be used in the following formula for converted to a score of 0-100 : (sum of scores) x 25 / (# of questions answered), where 0 represents normality or non-symptomatology and 100 the most severe case. Will be used to measure the symptoms of dry eye disease by obtaining baseline data and comparing them against the last visit.


Secondary Outcome Measures :
  1. Schirmer Test [ Time Frame: Day 60 ]

    Change from Baseline in Schirmer test after 60 days of treatment

    Schirmer test

    It is the technique most used to measure aqueous and at the same time the simplest tear secretion. It is carried out as follows: Without applying anesthesia, the patient is placed somewhere without much illumination, without applying anesthesia, a strip of filter paper of approximately 30 mm is placed, of which, 5 mm must go in the joint Of the middle and outer third of the lower eyelid. The patient is instructed to look forward and to blink normally. After 5 minutes the strips are removed and the wetting is recorded in millimeters. A test less than or equal to 6 mm is diagnostic of aqueous deficiency.The mean of the revisions by group will be compared at the baseline and final visit.


  2. Tear Film Break up Time [ Time Frame: Day 60 ]
    Change from Baseline in Tear film break up time after 60 days of treatment Tear film breakup time is the elapsed time from blinking to the first occurrence of a dry area in the cornea, visualized with the help of fluorescein staining. Measurement of tear film breakup time will be performed as follows: Fluorescein is instilled in the eye, the patient is asked to blink three times to distribute the dye and then set the eye to the front and do not blink while the examiner observes the cornea with cobalt blue light, looking for an area of tear film rupture, which is manifested by the appearance of a black island within the fluorescein green film. Normally film breakup time is 10 seconds or more and the minimum register may be 1 second, Under 10 seconds is considered abnormal.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657253


Locations
Mexico
Consultorio privado
Guadalajara, Jalisco, Mexico, 44600
Sponsors and Collaborators
Laboratorios Sophia S.A de C.V.
Investigators
Study Director: Leopoldo M Baiza-Durán, MD Laboratorios Sophia S.A de C.V.
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier: NCT01657253     History of Changes
Other Study ID Numbers: SOPH148-0512/III
First Posted: August 6, 2012    Key Record Dates
Results First Posted: December 15, 2017
Last Update Posted: December 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The personal data of the study subjects were treated with Confidentiality policy.

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