- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01657253
Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye
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 Overview
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Jalisco
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Guadalajara, Jalisco, Mexico, 44600
- Consultorio Privado
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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 |
Instill 1 drop in each eye four times a day, for 60 days
Other Names:
|
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 |
Instill 1 drop in each eye four times a day, for 60 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 60
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Day 60
|
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.
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Day 60
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Leopoldo M Baiza-Durán, MD, Laboratorios Sophia S.A de C.V.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOPH148-0512/III
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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