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

Moderate to Severe Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01311609
• Other study ID #: C-11-005
• Status: Completed
• Phase: Phase 4
• First received: March 8, 2011
• Last updated: January 31, 2012
• Start date: November 2010
• Est. completion date: July 2011

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Moderate to Severe Dry Eye

Intervention

Other:
• Systane
Systane Lubricant Eye Drops [1-2 Drops in each eye four times daily (QID)]

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Staining		Visit 2 (Week 2) - change from baseline	No
Primary	Best-corrected visual acuity		Visit 2 (Week 2) - change from baseline	No