To Evaluate the Physical Effects of Systane(R) Lubricant Eye Drops Compared to Refresh Tears(R) Lubricant Eye Drops

This is a multi-site, randomized, investigator-masked study to evaluate the physical effects of Systane(R) versus Refresh Tears(R) in subjects with moderate to severe dry eye. It is a 6-week, perspective, randomized, active-controlled, investigator-masked, parallel group study.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Other: Systane; Other: Refresh Tears

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Channai
    • Saidapet, Channai, India, 600 015
      • Vasan Eye Care Hospital

Participation Criteria

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:

• Patient must be 18 years of age or older of any sex and any race, with a score of at least 2 (some of the time) on the subject-assessed Symptom Eligibility question.
• A sodium fluorescein corneal staining sum of ≥ 3 in either eye.
• A best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using 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 greater than 6 months prior to the initiation of the study.
• A history of intolerance or hypersensitivity to any component of the study medications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Systane; Systane Lubricant Eye Drops	Other: Systane; Systane Lubricant Eye Drops (1-2 drops in each eye, four times per day)
Experimental: Refresh Tears; Refresh Tears Lubricant Eye Drops	Other: Refresh Tears; Refresh Tears Lubricant Eye Drops (1-2 drops in each eye, four times per day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate physical effects of Systane and Refresh Tears in subjects to moderate to severe dry eye.	This is a descriptive study in which changes from baseline in Tear Break up Time, corneal staining, and the Ocular Symptoms Questionnaire will be evaluated by treatment group at every visit. The outcome of the IDEEL questionnaire at Visit 3 will be compared to Visit 1 by treatment group; the results of treatment satisfaction questionnaires will be tabulated by treatment at Visit 3.	Baseline to visit 3 (Day 42)

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: July 9, 2010
• First Submitted That Met QC Criteria: July 9, 2010
• First Posted (Estimate): July 12, 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

• Keywords: Dry Eye; Systane; Refresh Tears; Moderate to Severe Dry Eye
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: SMA-09-67