Status:
COMPLETED
To Evaluate the Physical Effects of Systane(R) Lubricant Eye Drops Compared to Refresh Tears(R) Lubricant Eye Drops
Lead Sponsor:
Alcon Research
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
NA
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, perspect...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01160133
Start Date
July 1 2010
End Date
June 1 2011
Last Update
April 10 2012
Active Locations (1)
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1
Vasan Eye Care Hospital
Saidāpet, Channai, India, 600 015