An Open-Label, Single-Center Study Evaluating the Effect of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in Patients Diagnosed With Dry Eye

April 7, 2012 updated by: Alcon Research
The purpose of this study is to evaluate the effect of acute and repeat dosing of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in a population of dry eye patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have history of mild-moderate dry eye with use of (or desire to use) eye drops in past 6 months

Exclusion Criteria:

  • Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Balance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SYSTANE® Balance Lubricant Eye Drops
SYSTANE Balance Lubricant Eye Drops dosed (bilaterally) in the office during each visit. Between visits 2 and 3, patients will dose 4 times per day for the 7 day period.
Other: SYSTANE® Balance Lubricant Eye Drops
Subjects will be dosed (bilaterally) in the office during each visit. Between visits 2 and 3, patients will dose 4 times per day for the 7 day period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in video Ocular Protection Index 10 and 55 minutes following Systane Balance instillation at Days 1 and 7.
Time Frame: 8 days
8 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in blink pattern in subjects with mean Interblink Interval (IBI) < 3 seconds at Days 2 and 8
Time Frame: 9 days
9 days
Fluorescein staining at Visits 1 & 3 on the Ora staining scale
Time Frame: 9 days
9 days
Ocular Symptomology at each visit
Time Frame: 9 days
9 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

October 15, 2010

First Submitted That Met QC Criteria

October 15, 2010

First Posted (ESTIMATE)

October 18, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 10, 2012

Last Update Submitted That Met QC Criteria

April 7, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMA-09-64

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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