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

Information source: Bausch & Lomb Incorporated
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Inflammation; Uveitis

Intervention: Fluocinolone Acetonide 0.59 mg (Procedure); Fluocinolone Acetonide 2.1 mg (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Bausch & Lomb Incorporated

Official(s) and/or principal investigator(s):
Johnson Varughese, Study Director, Affiliation: Valeant Pharmaceuticals/Bausch & Lomb

Overall contact:
Anya Loncaric, Phone: 510-782-2286, Email: aloncaric@solta.com

Summary

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

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Corneal Endothelial Cell Density

Eligibility

Minimum age: 6 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Anya Loncaric, Phone: 510-782-2286, Email: aloncaric@solta.com

Ophthalmic Partners of Boston, Boston, Massachusetts 02114, United States; Recruiting
Michael Raziman, MD
Additional Information

Starting date: August 2006
Last updated: February 13, 2015

Page last updated: August 23, 2015

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