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

NCT01160133 | Completed

• 1 other identifier: SMA-09-67
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye

Keywords

Systane; Refresh Tears; Dry Eye; Moderate to Severe Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Systane

EXPERIMENTAL

Systane Lubricant Eye Drops

Other: Systane

Refresh Tears

EXPERIMENTAL

Refresh Tears Lubricant Eye Drops

Other: Refresh Tears

Interventions

Systane OTHER

Systane Lubricant Eye Drops (1-2 drops in each eye, four times per day)

Systane

Refresh Tears OTHER

Refresh Tears Lubricant Eye Drops (1-2 drops in each eye, four times per day)

Refresh Tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Vasan Eye Care Hospital

Saidāpet, Channai, 600 015, India

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 12, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 10, 2012

Record last verified: 2012-01

Locations

IN (1)