Change in Ocular Flora Resistance From Repeated Topical Antibiotic Use
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| ClinicalTrials.gov Identifier: NCT01181713 |
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Recruitment Status :
Completed
First Posted : August 13, 2010
Last Update Posted : March 18, 2021
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Sponsor:
Sunnybrook Health Sciences Centre
Collaborator:
Novartis
Information provided by (Responsible Party):
Dr. Peter Kertes, Sunnybrook Health Sciences Centre
| Tracking Information | ||||||||||
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| First Submitted Date | February 8, 2010 | |||||||||
| First Posted Date | August 13, 2010 | |||||||||
| Last Update Posted Date | March 18, 2021 | |||||||||
| Study Start Date | June 2010 | |||||||||
| Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
ocular flora resistance to 4th generation fluoroquinolone [ Time Frame: 1 year ] Outcome will examine the change in amount, type and antibiotic resistance profile of ocular surface flora over the 3 months. Charcoal swab of the conjunctiva will be cultured, organisms grown will be identified and resistance to moxifloxacin will be quantified by minimal inhibitory resistance (MIC).
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| Original Primary Outcome Measures |
ocular flora resistance to 4th generation fluoroquinolone [ Time Frame: pre and post intravitreal injection for 3 months ] Outcome will examine the change in amount, type and antibiotic resistance profile of ocular surface flora over the 3 months. Charcoal swab of the conjunctiva will be cultured, organisms grown will be identified and resistance to moxifloxacin will be quantified by minimal inhibitory resistance (MIC).
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| Change History | ||||||||||
| Current Secondary Outcome Measures | Not Provided | |||||||||
| Original Secondary Outcome Measures | Not Provided | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Change in Ocular Flora Resistance From Repeated Topical Antibiotic Use | |||||||||
| Official Title | Antibiotic Resistance of Ocular Surface Flora After Continued Use of Topical Antibiotics Post Intravitreal Injections | |||||||||
| Brief Summary | The purpose of this study is to determine if antibiotic resistance of the ocular surface flora to the 4th generation fluoroquinolones will increase after repeated use of topical antibiotics for three days post intravitreal injection. | |||||||||
| Detailed Description | Treatment with intravitreal (IVT) injections has increased during the last several years as evidence has accumulated demonstrating the efficacy of anti-vascular endothelial growth factor agents in the treatment of neovascular age-related macular degeneration (AMD) and various retinal vascular diseases. Although IVT injections are generally safe, infectious endophthalmitis is a rare but devastating complication, and the risk of morbidity and vision loss from endophthalmitis is high. The objective is to examine the change in antibiotic resistance of ocular surface flora with repeated prophylactic use of antibiotics after IVT injection for AMD. Yin, V. T., Weisbrod, D. J., Eng, K. T., Schwartz, C., Kohly, R., Mandelcorn, E., Lam, W., Daneman, N., Simor, A., & Kertes, P. J. (2013). Antibiotic resistance of ocular surface flora with repeated use of a topical antibiotic after intravitreal injection. JAMA ophthalmology, 131(4), 456-461. |
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| Study Type | Observational | |||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | Patient recruitment would be from the Sunnybrook Health and Sciences Centre Department of Ophthalmology | |||||||||
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| Intervention | Not Provided | |||||||||
| Study Groups/Cohorts |
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| Publications * | Yin VT, Weisbrod DJ, Eng KT, Schwartz C, Kohly R, Mandelcorn E, Lam WC, Daneman N, Simor A, Kertes PJ. Antibiotic resistance of ocular surface flora with repeated use of a topical antibiotic after intravitreal injection. JAMA Ophthalmol. 2013 Apr;131(4):456-61. doi: 10.1001/jamaophthalmol.2013.2379. | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
200 | |||||||||
| Original Estimated Enrollment |
168 | |||||||||
| Actual Study Completion Date | December 2011 | |||||||||
| Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 65 Years and older (Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Canada | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT01181713 | |||||||||
| Other Study ID Numbers | SBK-OcuFResis | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | Dr. Peter Kertes, Sunnybrook Health Sciences Centre | |||||||||
| Study Sponsor | Sunnybrook Health Sciences Centre | |||||||||
| Collaborators | Novartis | |||||||||
| Investigators |
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| PRS Account | Sunnybrook Health Sciences Centre | |||||||||
| Verification Date | March 2021 | |||||||||