Product Preference With Systane Compared to Artificial Tears on Frequency of Drop Use
Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00347984
Collaborator
ORA, Inc. (Industry)
50
1
2
24.5
Study Details
Study Description
Brief Summary
The objective of this study was to evaluate the effect of Systane® compared to marketed artificial tears on the frequency of drop use.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
The Effect of Systane® Compared to Marketed Artificial Tears on Frequency of Drop Use
Study Start Date
:
Dec 1, 2005
Actual Primary Completion Date
:
Feb 1, 2006
Actual Study Completion Date
:
Feb 1, 2006
Outcome Measures
Primary Outcome Measures
- Frequency of drop use and/or desire to use; Drop preference []
Secondary Outcome Measures
- Product questionnaire; Symptoms; Corneal and conjunctival staining; Tear film break-up time (TFBUT). []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Subjects age 18 (minimum); reported history of dry eye syndrome in both eyes; TFBUT ≤ 7 seconds in at least 1 eye at Visit 1; ≥ 1+ fluorescein staining score in any region in at least 1 eye at Visit 1; desire to use an artificial tear substitute for dry eye symptoms at least 4 times per day at Visit 1 and Visit 2.
Exclusion Criteria:
- Age less than 18 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Maryland | Andover | Massachusetts | United States | 01845 |
Sponsors and Collaborators
- Alcon Research
- ORA, Inc.
Investigators
- Study Director: Mike Christensen, Alcon Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00347984
Other Study ID Numbers:
- 05-004-09
First Posted:
Jul 4, 2006
Last Update Posted:
Apr 10, 2012
Last Verified:
Aug 1, 2008