Status:
COMPLETED
Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining
Lead Sponsor:
Alcon Research
Conditions:
Dry Eye Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® U...
Detailed Description
Following a 2-week washout phase with saline eye drops, subjects were randomized to receive either Systane® ULTRA or OPTIVE® for the remainder of the study.
Eligibility Criteria
Inclusion
- Willing and able to attend all study visits.
- Diagnosis of dry eye, as specified in protocol.
- Uses artificial tears, as specified in protocol.
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Poor visual acuity, as specified in protocol.
- Women of childbearing potential who are pregnant, lactating, or not using adequate birth control, as specified in protocol.
- Any hypersensitivity or allergy to the investigational products or ingredients.
- Any eye disorder, ocular surgery, medication, medical condition, or systemic disease, as specified in protocol.
- Contact lens use within 2 weeks of Screening Visit.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01863368
Start Date
September 1 2013
End Date
June 1 2014
Last Update
August 4 2015
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