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NCT01060787 Clinical Trial

Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant

Inflammation Clinical Trial

Official title:
An Observational Bilateral Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant for at Least One Year

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01060787
Other study ID # 440
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 4, 2016
Est. completion date June 7, 2019

Study information
Verified date June 2019
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants

Description:

Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants on corneal endothelial cell density.

Recruitment information / eligibility
Status Completed
Enrollment 98
Est. completion date June 7, 2019
Est. primary completion date March 7, 2019
Accepts healthy volunteers No
Gender All
Age group 6 Years and older
Eligibility Inclusion Criteria:

- Had the FA intravitreal implant (0.59 or 2.1 mg) in only one eye for at least one(1) year

- Able and willing to follow instructions

- Able and willing to provide informed consent

Exclusion criteria:

- Is monocular

- Has current or relevant medical history that would interfere with their participation in this study, based on the judgment of the Investigator

- Had bilateral FA intravitreal implants

- Has a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Fluocinolone Acetonide 0.59 mg
At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density.
• Fluocinolone Acetonide 2.1 mg
At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density.

Locations
Country Name City State
United States Ophthalmic Partners of Boston Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Corneal Endothelial Cell Density Bilateral specular microscopy will be performed and endothelial cell density will be recorded. 1 Visit
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