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

• ClinicalTrials.gov Identifier: NCT01881438
• Recruitment Status: Completed
• First Posted: June 19, 2013
• Last Update Posted: June 19, 2013
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Study Description

Brief 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.

Condition or disease
Retinal Detachment

Detailed 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).

Study Design

• Study Type: Observational
• Actual Enrollment: 119924 participants
• Time Perspective: Retrospective
• Official Title: Oral Fluoroquinolones and the Risk of Retinal Detachment
• Study Start Date: January 2000
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: May 2013

Groups and Cohorts

Group/Cohort
Participants exposed to oral fluoroquinolones; Oral fluoroquinolones in this study are ciprofloxacin, levofloxacin, gatifloxacin, gemifloxacin, moxifloxacin, norfloxacin, and ofloxacin.

Outcome Measures

Primary Outcome Measures :

1. Number of Retinal Detachments With Exposure to Oral Ciprofloxacin or to Oral Fluoroquinolones [ Time Frame: 11 years ]
   Oral fluoroquinolones in this study are gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin.

Secondary Outcome Measures :

1. Number of Retinal Detachments With Exposure to Oral Ciprofloxacin or to Oral Fluoroquinolones (Revised Case-Control Design) [ Time Frame: 11 years ]
   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.
2. Number of Retinal Detachments With Exposure to Individual Oral Fluoroquinolones (Revised Case-Control Design) [ Time Frame: 11 years ]
   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.
3. Number of Retinal Detachments With Exposure to Oral Fluoroquinolones Along With Oral Beta-Lactam antibiotic (Case-Control Design) [ Time Frame: 11 years ]
   Oral fluoroquinolones in this study are gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin. Case-control design is used for assessment of this outcome measure.
4. Number of Retinal Detachments With Exposure to Oral Levofloxacin and Ciprofloxacin (Cohort Design) [ Time Frame: 11 years ]
   Cohort design is used for assessment of this outcome measure.
5. Number of Retinal Detachments During the Period of Exposure With Oral Levofloxacin and Ciprofloxacin (Case-Only Design) [ Time Frame: 11 years ]
   Case-only design is used for assessment of this outcome measure.
6. Number of Retinal Detachments During the Period of non-Exposure to Oral Levofloxacin and Ciprofloxacin (Case-Only Design) [ Time Frame: 11 years ]
   Case-only design is used for assessment of this outcome measure.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Participants with exposure to oral fluoroquinolones

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

More Information

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT01881438 History of Changes
• Other Study ID Numbers: CR100940; RRA-7875 ( Other Identifier: Janssen Research & Development, LLC )
• First Posted: June 19, 2013
• Last Update Posted: June 19, 2013
• Last Verified: June 2013

Keywords provided by Janssen Research & Development, LLC:

Retinal Detachment; Fluoroquinolones; Ciprofloxacin; Levofloxacin; Gatifloxacin; Gemifloxacin; Moxifloxacin; Norfloxacin; Ofloxacin; Beta-Lactam

Additional relevant MeSH terms:

Retinal Detachment; Dissociative Disorders; Mental Disorders; Retinal Diseases; Eye Diseases; Levofloxacin; Ciprofloxacin; Fluoroquinolones; Gatifloxacin; Norfloxacin; Anti-Bacterial Agents; Anti-Infective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Anti-Infective Agents, Urinary; Renal Agents; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; Ophthalmic Solutions; Pharmaceutical Solutions