A Multi-Site Post Marketing Surveillance Study for Systane in Indian Patients
Phase 4
Completed
- Conditions
- Moderate to Severe Dry Eye
- Interventions
- Other: Systane
- Registration Number
- NCT01311609
- Lead Sponsor
- Alcon Research
- Brief Summary
This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the physical effects of Systane Lubricant Eye Drops.
- Detailed Description
This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the physical effects of Systane Lubricant Eye Drops. The assessed effects include: corneal and conjunctival staining, and ocular signs and symptoms. This is a two week prospective study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- 18 years of age or older, of both sexes, and any race.
- Willing and able to make all required visits and follow study instructions.
- A sodium fluorescein corneal staining sum of >/ 3 in either eye. A best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed during an ETDRS chart
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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 > 6 months prior to the initiation of the study.
- A history of intolerance or hypersensitivity to any component of the study medications.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Systane Systane Systane Lubricant Eye Drops
- Primary Outcome Measures
Name Time Method Best-corrected visual acuity Visit 2 (Week 2) - change from baseline Corneal Staining Visit 2 (Week 2) - change from baseline
- Secondary Outcome Measures
Name Time Method