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

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

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).

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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

Resource links provided by the National Library of Medicine


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



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.



Information from the National Library of Medicine

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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881438


Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

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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    Key Record Dates
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:
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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