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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Moderate to Severe Dry Eye

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Systane

Systane Lubricant Eye Drops

Group Type EXPERIMENTAL

Systane

Intervention Type OTHER

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

Interventions

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Systane

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No