Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome (PRO-148)
|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: NCT01541891|
Recruitment Status : Unknown
Verified February 2012 by Laboratorios Sophia S.A de C.V..
Recruitment status was: Active, not recruiting
First Posted : March 1, 2012
Last Update Posted : March 1, 2012
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndrome||Drug: PRO-148 Ophthalmic Solution Drug: Active Comparator: SYSTANE ® Ophthalmic Solution||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||STUDY TO COMPARATIVE THE EFFICACY AND SAFETY OF PRO-148 OPHTHALMIC SOLUTION VS.SYSTANE® IN THE TREATMENT OF MILD-TO-MODERATE DRY EYE SYNDROME|
|Study Start Date :||September 2011|
|Primary Completion Date :||February 2012|
|Experimental: Arm A PRO 148 Ophthalmic Solution||
Drug: PRO-148 Ophthalmic Solution
PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.
|Active Comparator: Arm B. SYSTANE® Ophthalmic Solution||
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.
- Efficacy outcomes measures. [ Time Frame: During 60 days ]
- 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.
- Safety outcomes measures. [ Time Frame: During 60 days ]
- 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.
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): NCT01541891
|Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"|
|Guadalajara, Jalisco, Mexico, 44280|
|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|