Evaluation of SYSTANE Ultra Lubricant Eye Drops

Dry Eye Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702377
• Other study ID #: C-07-33
• Status: Completed
• Phase: N/A
• First received: June 19, 2008
• Last updated: January 31, 2012
• Start date: June 2008
• Est. completion date: September 2008

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented diagnosis of dry eyes

• Must not have worn contact lenses for 1 week preceding enrollment

Exclusion Criteria:

• Age related

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye

Intervention

Other:
• SYSTANE Ultra
SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
• Optive
Optive Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days

Locations

Country	Name	City	State
United States	Contact Call Center for Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear Break-up Time	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.	Day 0, Day 7, Day 14, Day 28, and Day 42	No
Primary	Conjunctival Staining	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.	Day 0, Day 7, Day 14, Day 28, Day 42	No
Primary	Corneal Staining	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.	Day 0, Day 7, Day 14, Day 28, Day 42	No