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NCT00673764 Clinical Trial

The Effect of Systane Ultra Lubricant Eye Drops (FID 112903) on Visual Performance

Dry Eye Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00673764
Other study ID # C-07-24
Secondary ID
Status Completed
Phase N/A
First received May 2, 2008
Last updated January 31, 2012
Start date May 2008
Est. completion date June 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 effect of 2 different lubricant eye drops on visual function of patients with dry eye

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Months and older
Eligibility Inclusion Criteria:

- Documented diagnosis of dry eye

- Must not have worn contact lenses for 12 hours prior to Day 1

Exclusion Criteria:

- Age related

Study Design

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

Related Conditions & MeSH terms

Intervention

Other:
• Systane Ultra Lubricant Eye Drops
Systane Ultra Lubricant Eye Drops 1 drop each eye one time
• Optive Lubricant Eye Drops
Optive Lubricant Eye Drops 1 drop each eye one time

Locations
Country Name City State
United States North Andover North Andover Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time at Best Corrected Visual Acuity Measuring length of time patient can maintain their best vision while completing a computer task. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Corrected visual acuity means the patient can wear glasses or contacts if needed such that the measure is performed with the patient seeing the best that they can. 15 minutes, 45 minutes, and 90 minutes post-dose No
Secondary Functional Blink Rate Time (Time Between Blinks) Measures time in seconds between normal blinks. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Longer blink rate time correlates with improved visual performance. 15 minutes, 45 minutes, and 90 minutes post-dose No
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