Back to resultsEfficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye
Primary Purpose
Dry Eye
Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
PRO-148
Systane
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility 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
Sites / Locations
- Consultorio privado
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PRO-148
Systane®
Arm Description
PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution doses: 1 drop in each eye, quarter in day
Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar doses: 1 drop in each eye, quarter in day
Outcomes
Primary Outcome Measures
Ocular Surface Disease Index (OSDI©) Questionnaire
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
Schirmer Test
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.
Tear Film Break up Time
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.
Full Information
NCT ID
NCT01657253
First Posted
July 19, 2012
Last Updated
May 8, 2017
Sponsor
Laboratorios Sophia S.A de C.V.
1. Study Identification
Unique Protocol Identification Number
NCT01657253
Brief Title
Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye
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 Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
April 2015 (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 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®
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
183 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRO-148
Arm Type
Experimental
Arm Description
PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution
doses: 1 drop in each eye, quarter in day
Arm Title
Systane®
Arm Type
Active Comparator
Arm Description
Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar
doses: 1 drop in each eye, quarter in day
Intervention Type
Drug
Intervention Name(s)
PRO-148
Other Intervention Name(s)
PRO-148 (xanthan gum and sulphate chondroitin)
Intervention Description
Instill 1 drop in each eye four times a day, for 60 days
Intervention Type
Drug
Intervention Name(s)
Systane
Other Intervention Name(s)
polyethyleneglycol 400, propyleneglycol, hydroxypropyl guar
Intervention Description
Instill 1 drop in each eye four times a day, for 60 days
Primary Outcome Measure Information:
Title
Ocular Surface Disease Index (OSDI©) Questionnaire
Description
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.
Time Frame
Day 60
Secondary Outcome Measure Information:
Title
Schirmer Test
Description
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.
Time Frame
Day 60
Title
Tear Film Break up Time
Description
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.
Time Frame
Day 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leopoldo M Baiza-Durán, MD
Organizational Affiliation
Laboratorios Sophia S.A de C.V.
Official's Role
Study Director
Facility Information:
Facility Name
Consultorio privado
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44600
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The personal data of the study subjects were treated with Confidentiality policy.
Citations:
PubMed Identifier
27645318
Citation
Perez-Balbuena AL, Ochoa-Tabares JC, Belalcazar-Rey S, Urzua-Salinas C, Saucedo-Rodriguez LR, Velasco-Ramos R, Suarez-Sanchez RG, Rodriguez-Carrizalez AD, Oregon-Miranda AA. Efficacy of a fixed combination of 0.09 % xanthan gum/0.1 % chondroitin sulfate preservative free vs polyethylene glycol/propylene glycol in subjects with dry eye disease: a multicenter randomized controlled trial. BMC Ophthalmol. 2016 Sep 20;16(1):164. doi: 10.1186/s12886-016-0343-9.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye
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