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NCT00946777 Clinical Trial

Barrier Function Measurement in Dry Eye Patients After Using Systane Ultra for 30 Days

Dry Eye Clinical Trial

Official title:
Barrier Function Measurement in Dry Eye Patients After Using Systane Ultra for 30 Days

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00946777
Other study ID # SMA-09-04
Secondary ID
Status Completed
Phase N/A
First received July 24, 2009
Last updated November 17, 2016
Start date July 2009
Est. completion date September 2009

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 primary objective is to determine if there is a correlation between reductions in corneal staining and improvements in corneal barrier function.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients must have moderate corneal staining and exhibit a need to use artificial tears.

Exclusion Criteria:

- Patients can not participate in any other ophthalmic drug or device clinical trial within 30 days of the baseline visit.

Study Design

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

Related Conditions & MeSH terms

Intervention

Other:
• Systane® Ultra
Systane® Ultra 1-2 drops, 4 times per day for 30 days

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

References & Publications (1)

Fernandez KB, Epstein SP, Raynor GS, Sheyman AT, Massingale ML, Dentone PG, Landegger LD, Asbell PA. Modulation of HLA-DR in dry eye patients following 30 days of treatment with a lubricant eyedrop solution. Clin Ophthalmol. 2015 Jun 24;9:1137-45. doi: 10 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percent change from baseline of corneal fluorescein 30 days No
Secondary Adverse event occurence 30 Days Yes
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