Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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®

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Sophia S.A de C.V.

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