Systane Clinical Experience Study

This study has been completed.
Sponsor:
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
  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 April 17, 2014