Overview

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