An Observational Study of Oral Fluoroquinolones and the Risk of Retinal Detachment

Retinal Detachment Clinical Trial

Official title:

Oral Fluoroquinolones and the Risk of Retinal Detachment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881438
• Other study ID #: CR100940
• Secondary ID: RRA-7875
• Status: Completed
• Phase: Phase 4
• First received: June 17, 2013
• Last updated: June 18, 2013
• Start date: January 2000
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: None due to nature of the study
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess the association of retinal detachment (separation of the retina [the innermost layer of the eyeball] from its connection at the back of the eye) with exposure to oral ciprofloxacin or oral fluoroquinolones.

Description:

This is an observational (in which the investigators observe the outcomes of the study participants but do not intervene by, e.g, assigning the treatments) and retrospective (a study in which the exposures and outcomes occurred before the study began) study. It will use data from the Optuminsight and Truven Commercial Claims and Encounters databases, each of which will be evaluated separately using 3 designs: (1) Case-control (a design that compares the cases [study participants], ie, those with retinal detachment to controls, ie, a sample of similar people who did not have a retinal detachment) to assess whether their exposures to fluoroquinolones (FQs) differed. Two case-control studies are planned, one (replication) that mimics a previously reported study, the other (revised) that addresses more potential confounders than did that study , (2) Cohort (a design that follows the participants exposed to FQs and those not exposed to FQs to assess whether the two groups had different risks of developing retinal detachment), (3) Case-only (a design where the exposure history of individuals who had retinal detachment are examined to assess whether they were more likely to have had it when they were exposed to FQs than when they were not).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119924
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion criteria:

• At least 1 year of enrollment in the study for medical and pharmacy benefits after their cohort (group) entry (the day of their first ophthalmologist visit) for case-control design

• Oral fluoroquinolone like levofloxacin or ciprofloxacin must be dispensed to participants for cohort design

• At least one visit to an ophthalmologist and enrolled at least for 1 year in the study for medical and pharmacy benefits prior to the date of first occurrence of the exposure of levofloxacin or ciprofloxacin for cohort design

• At least one visit to an ophthalmologist and enrolled at least for 1 year in the study for medical and pharmacy benefits prior to the diagnosis of their first retinal detachment (separation of the retina [the innermost layer of the eyeball] from its connection at the back of the eye) for case-only design

Exclusion criteria:

• Prior diagnosis of retinal detachment , prior diagnosis or procedure for inflammatory conditions of the eyeball, or hospital admission between cohort entry and the date of the retinal detachment

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Retinal Detachment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Retinal Detachments With Exposure to Oral Ciprofloxacin or to Oral Fluoroquinolones	Oral fluoroquinolones in this study are gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin.	11 years	Yes
Secondary	Number of Retinal Detachments With Exposure to Oral Ciprofloxacin or to Oral Fluoroquinolones (Revised Case-Control Design)	Oral fluoroquinolones in this study are gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin. Revised Case-control design is used for assessment of this outcome measure.	11 years	Yes
Secondary	Number of Retinal Detachments With Exposure to Individual Oral Fluoroquinolones (Revised Case-Control Design)	Oral fluoroquinolones in this study are gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin. Revised Case-control design is used for assessment of this outcome measure.	11 years	Yes
Secondary	Number of Retinal Detachments With Exposure to Oral Fluoroquinolones Along With Oral Beta-Lactam antibiotic (Case-Control Design)	Oral fluoroquinolones in this study are gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin. Case-control design is used for assessment of this outcome measure.	11 years	Yes
Secondary	Number of Retinal Detachments With Exposure to Oral Levofloxacin and Ciprofloxacin (Cohort Design)	Cohort design is used for assessment of this outcome measure.	11 years	Yes
Secondary	Number of Retinal Detachments During the Period of Exposure With Oral Levofloxacin and Ciprofloxacin (Case-Only Design)	Case-only design is used for assessment of this outcome measure.	11 years	Yes
Secondary	Number of Retinal Detachments During the Period of non-Exposure to Oral Levofloxacin and Ciprofloxacin (Case-Only Design)	Case-only design is used for assessment of this outcome measure.	11 years	Yes