In Vivo Measurement of Corneal Epithelial Changes in Dry Eye Patients

Dry Eye Syndrome Clinical Trial

Official title:

In Vivo Measurement of Corneal Epithelial Changes in Dry Eye(DE) Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483989
• Other study ID #: SMA-09-49
• Status: Completed
• Phase: N/A
• First received: November 29, 2011
• Last updated: November 17, 2016
• Start date: February 2011
• Est. completion date: June 2011

Study information

• Verified date: February 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to measure corneal epithelial changes in dry eye subjects using a novel lubricant eye gel.

Description:

The purpose of this study is to measure corneal epithelial changes in dry eye (DE) subjects using a novel lubricant eye gel.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects must have history of dry eye as determined by:

1. Questionnaire

2. Tear Film Break Up Time less than or equal to 10 seconds

3. Schirmer's score of less than or equal to 5 mm

4. Corneal staining greater than or equal to 3 in either eye, and

5. Positive for conjunctival staining (greater than or equal to 1)

Exclusion Criteria:

• Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Gel Drops.

Study Design

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

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• SYSTANE® Gel Drop lubricant eye gel
SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

References & Publications (1)

http://iovs.arvojournals.org/article.aspx?articleid=2351788

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.	The Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.	baseline and 28 days	No