Clinical Trial: Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
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
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.
Detailed Summary: A phase 2, randomized, double masked clinical, parallel-group clinical trial to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.
Sponsor: Laboratorios Sophia S.A de C.V.
Current Primary Outcome: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome: 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.
Original Secondary Outcome: Same as current
Information By: Laboratorios Sophia S.A de C.V.
Dates:
Date Received: February 20, 2012
Date Started: September 2011
Date Completion:
Last Updated: February 29, 2012
Last Verified: February 2012
