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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01311609
First received: March 8, 2011
Last updated: January 31, 2012
Last verified: January 2012
  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: Open Label
Primary Purpose: Treatment
Official Title: Multi-Site Post Marketing Surveillance Study for Systane in Indian Patients

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Corneal Staining [ Time Frame: Visit 2 (Week 2) - change from baseline ] [ Designated as safety issue: No ]
  • Best-corrected visual acuity [ Time Frame: Visit 2 (Week 2) - change from baseline ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01311609     History of Changes
Other Study ID Numbers: C-11-005
Study First Received: March 8, 2011
Last Updated: January 31, 2012
Health Authority: India: Drugs Controller General of India

Keywords provided by Alcon Research:
Systane, Dry Eye

ClinicalTrials.gov processed this record on November 24, 2014