A Multi-Site Post Marketing Surveillance Study for Systane in Indian Patients

Alcon Research300 enrolled

Overview

This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the physical effects of Systane Lubricant Eye Drops.

This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the physical effects of Systane Lubricant Eye Drops. The assessed effects include: corneal and conjunctival staining, and ocular signs and symptoms. This is a two week prospective study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Moderate to Severe Dry Eye

Interventions

SystaneOTHER

Systane Lubricant Eye Drops \[1-2 Drops in each eye four times daily (QID)\]

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age or older, of both sexes, and any race. * Willing and able to make all required visits and follow study instructions. * A sodium fluorescein corneal staining sum of \>/ 3 in either eye. A best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed during an ETDRS chart Exclusion Criteria: * A history or evidence of ocular or intraocular surgery in either eye within the past 6 months. * Lasik patients can be included if Lasik surgery was \> 6 months prior to the initiation of the study. * A history of intolerance or hypersensitivity to any component of the study medications.

Outcomes

Primary Outcomes

Corneal Staining

Time frame: Visit 2 (Week 2) - change from baseline

Best-corrected visual acuity

Time frame: Visit 2 (Week 2) - change from baseline

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.