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

Dry Eye Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01160133
• Other study ID #: SMA-09-67
• Status: Completed
• Phase: N/A
• First received: July 9, 2010
• Last updated: April 7, 2012
• Start date: July 2010
• Est. completion date: June 2011

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye

Intervention

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

Locations

Country	Name	City	State
India	Vasan Eye Care Hospital	Saidapet	Channai

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes