Expired Study
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San Antonio, Texas 78229


Purpose:

The clinical objective of this study is to quantify the levels of corneal and conjunctival staining in a healthy, non-dry eye population. This is a descriptive study without test article administered.


Criteria:

Inclusion Criteria: - Healthy eyes Exclusion Criteria: - Age related


Study is Available At:


Original ID:

C-06-23


NCT ID:

NCT00643942


Secondary ID:


Study Acronym:


Brief Title:

Staining in a Healthy, Non-Dry Eye Population


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: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

120


Enrollment Type:


Study Dates

Start Date:June 2007
Primary Completion Date:January 2008
Primary Completion Type:Actual
Verification Date:March 2008
Last Changed Date:May 8, 2015
First Received Date:March 24, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Corneal fluorescein staining scores
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:No intervention required
Arm Name:1

Study Arms

Study Arm Type:Other
Arm Name:1

Study Agencies

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

Samples and Retentions

Study Population: Patients with normal healthy eyes
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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