Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome (PRO-148)
|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.
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|