Systane Clinical Experience Study
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00818909
First received: January 7, 2009
Last updated: January 31, 2012
Last verified: January 2012
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Purpose
To evaluate the physical effect of SYSTANE QID in people that have moderate to severe dry eyes and to establish doctor confidence to prescribe Systane.
| Condition | Intervention | Phase |
|---|---|---|
|
Dry Eye Syndrome |
Other: Systane |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study to Evaluate the Physical Effect of SYSTANE QID in People That Have Moderate to Severe Dry Feeling Eyes |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- corneal and conjunctiva staining score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Tear film break up time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 941 |
| Study Start Date: | January 2009 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Systane
Systane ocular product
|
Other: Systane
Systane prescription
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- moderate to severe dry feeling eyes
Exclusion Criteria:
- None
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT00818909 History of Changes |
| Other Study ID Numbers: | CARES-3 |
| Study First Received: | January 7, 2009 |
| Last Updated: | January 31, 2012 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Alcon Research:
|
Dry eye Systane Moderate to severe dry eye |
Additional relevant MeSH terms:
|
Dry Eye Syndromes Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases Eye Diseases Keratoconjunctivitis |
Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013