Evaluation of SYSTANE Ultra Lubricant Eye Drops

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Other: SYSTANE Ultra; Other: Optive

• Registration Number: NCT00702377
• Lead Sponsor: Alcon Research

Brief Summary

To evaluate the safety and efficacy of two artificial tears in dry eye patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-19
• Study First Posted: 2008-06-20
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2009-09-23
• Results First Submitted QC: 2010-01-22
• Results First Posted: 2010-02-10
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-31
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• Documented diagnosis of dry eyes
• Must not have worn contact lenses for 1 week preceding enrollment

Exclusion Criteria

• Age related

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SYSTANE Ultra	SYSTANE Ultra	SYSTANE Ultra Lubricant Eye Drops
OPTIVE	Optive	OPTIVE Lubricant Eye Drops

Primary Outcome Measures

Name	Time	Method
Tear Break-up Time	Day 0, Day 7, Day 14, Day 28, and Day 42	Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp.
Conjunctival Staining	Day 0, Day 7, Day 14, Day 28, Day 42	Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining.
Corneal Staining	Day 0, Day 7, Day 14, Day 28, Day 42	Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining.

Trial Locations

Locations (1)

Contact Call Center for Locations; 🇺🇸 Fort Worth, Texas, United States