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A Multi-Site Post Marketing Surveillance Study for Systane in Indian Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01311609
First Posted: March 9, 2011
Last Update Posted: February 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  Purpose
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.

Condition Intervention Phase
Moderate to Severe Dry Eye Other: Systane Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-Site Post Marketing Surveillance Study for Systane in Indian Patients

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Corneal Staining [ Time Frame: Visit 2 (Week 2) - change from baseline ]
  • Best-corrected visual acuity [ Time Frame: Visit 2 (Week 2) - change from baseline ]

Enrollment: 300
Study Start Date: November 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Systane
Systane Lubricant Eye Drops
Other: Systane
Systane Lubricant Eye Drops [1-2 Drops in each eye four times daily (QID)]

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01311609     History of Changes
Other Study ID Numbers: C-11-005
First Submitted: March 8, 2011
First Posted: March 9, 2011
Last Update Posted: February 2, 2012
Last Verified: January 2012

Keywords provided by Alcon Research:
Systane, Dry Eye

Additional relevant MeSH terms:
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions