Expired Study
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Fort Worth, Texas 76134


Purpose:

To evaluate drop comfort, acceptability, preference and blue profile between two marketed artificial tears in both dry eyes and non-dry eye patient population.


Criteria:

Inclusion Criteria: - Documented diagnosis of dry eye Exclusion Criteria: - Use of contact lens within 7 days preceding enrollment


Study is Available At:


Original ID:

M-08-09


NCT ID:

NCT00748865


Secondary ID:


Study Acronym:


Brief Title:

Acute Comfort and Blur of Systane Ultra and Systane


Official Title:


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Alcon Research


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Cros


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Actual


Study Dates

Start Date:July 2008
Completion Date:August 2008
Completion Type:Actual
Primary Completion Date:August 2008
Primary Completion Type:Actual
Verification Date:January 2012
Last Changed Date:January 31, 2012
First Received Date:September 5, 2008
First Results Date:September 25, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:Drop Comfort
Time Frame:once upon instillation
Safety Issues:False
Description:Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable,

Study Interventions

Intervention Type:Other
Name:Systane Ultra Lubricant Eye Drops
Description:Systane Ultra Lubricant Eye Drops 1 drop each eye one time
Arm Name:Systane Ultra
Intervention Type:Other
Name:Systane Lubricant Eye Drops
Description:Systane Lubricant Eye Drops 1 drop each eye one time
Arm Name:Systane

Study Arms

Study Arm Type:Active Comparator
Arm Name:Systane
Description:Systane 1 drop each eye one time
Study Arm Type:Experimental
Arm Name:Systane Ultra
Description:Systane Ultra 1 drop each eye one time

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Alcon Research

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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