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

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ClinicalTrials.gov Identifier: NCT01311609
Recruitment Status : Completed
First Posted : March 9, 2011
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Moderate to Severe Dry Eye Other: Systane Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
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
Study Start Date : November 2010
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
Drug Information available for: Systane
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Systane
Systane Lubricant Eye Drops
Other: Systane
Systane Lubricant Eye Drops [1-2 Drops in each eye four times daily (QID)]


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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.
More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01311609     History of Changes
Other Study ID Numbers: C-11-005
First Posted: March 9, 2011    Key Record Dates
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