The Clinical Safety of Levofloxacin 1.5% vs Topical Moxifloxacin 0.5%
NCT ID: NCT04212429
Last Updated: 2020-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
128 participants
INTERVENTIONAL
2019-09-23
2022-05-31
Brief Summary
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Endophthalmitis can progress into panophthalmitis, corneal infiltration and perforation, and finally phthisis bulbi. For exogenous endopthalmitis, the intraocular inflammation occurs due to a breach of the ocular compartment. The infectious agent indirectly introduced into the eye. This usually happens after intraocular surgery such as cataract surgery, vitrectomy, glaucoma filtration surgery, intravitreal injections, and other causes include penetrating ocular trauma or from adjacent periocular tissue. Several prophylactic measures have been taken to reduce the incidence of post-operative endopthalmitis postcataract surgery, this includes the use of pre-operative topical levofloxacin, intrameral cefuroxime, and providone iodine as ocular surface preparation.The proposed study is to evaluate clinical safety of Levofloxacin 1.5% and Moxifloxacin 0.5% on the anterior segment parameters.
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Detailed Description
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The qualified patients will be randomized on a 1:1 ratio into each treatment arm. Qualified eyes were further randomized into one of four subgroups, which specified the time between the last drop of study medication and the time of aqueous and vitreous humor sample collection (i.e., 1-, 2-, 4-, and 6-hour subgroups- about 32 patients per subgroup-: 16 Levofloxacin, 16 Moxifloxacin.
Patient will undergo clinical assessment at the outpatient Ophthalmology Clinic at UKMMC. Initially, a non-contact assessment of the corneal surface will be done by the Keratograph 5. The parameters recorded are non-invasive tear break up time (NITBUT), tear film properties and redness analysis. The endothelial cell count will be analysed with a specular microscopy. Subsequently, patient will be assessed by a blinded ophthalmologist for clinical evaluation of corneal surface which includes tear break up time (TBUT), ocular surface abnormality and Rose-bengal staining. During the first visit, each patient will be educated on proper instillation of the eye drops to ensure the proper dose is administered. A prior observation of self- instillation of the eye drop by the study staff is required.
For 3 days prior to the day of the elective vitrectomy surgery, subjects will instill exactly one drop of study medication into their operative eye four times daily. On the day of surgery (visit 2, day 4), patients will receive their final drop of study medication administered by trained study personnel at the study site.
Post-vitrectomy, patients will be continued on the specified antibiotics for 4 hourly for 2 weeks. Then the antibiotic will taper down to 6 hourly (QID) daily for 1 week and antibiotics will be discontinued after that. Corneal safety will be assessed at 1 week and 4 weeks post operatively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Levofloxacin -1 hour group
Levofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 1-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection.
Levofloxacin Ophthalmic Product
Levofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation.
Levofloxacin-2 hour group
Levofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 2-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection.
Levofloxacin Ophthalmic Product
Levofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation.
Levofloxacin-4 hour group
Levofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 4-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection.
Levofloxacin Ophthalmic Product
Levofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation.
Levofloxacin-6 hour group
Levofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 6-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection.
Levofloxacin Ophthalmic Product
Levofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation.
Moxifloxacin-1 hour group
Moxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 1-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection.
Moxifloxacin Ophthalmic Solution
Moxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation.
Moxifloxacin-2 hour group
Moxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 2-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection.
Moxifloxacin Ophthalmic Solution
Moxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation.
Moxifloxacin-4 hour group
Moxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 4-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection.
Moxifloxacin Ophthalmic Solution
Moxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation.
Moxifloxacin-6 hour group
Moxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily (8am, 12pm, 4pm, 8pm) for 3 days prior to the surgery. On the day of surgery, there will be 8-hour gap between last drop of study medication and the time of aqueous and vitreous humor sample collection.
Moxifloxacin Ophthalmic Solution
Moxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation.
Interventions
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Levofloxacin Ophthalmic Product
Levofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation.
Moxifloxacin Ophthalmic Solution
Moxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 and above
* Not on any topical medication
Exclusion Criteria
* Fluoroquinolone allergy
18 Years
ALL
No
Sponsors
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Santen Pharmaceutical Co., Ltd.
INDUSTRY
National University of Malaysia
OTHER
Responsible Party
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Wan Haslina Wan Abdul Halim
Consultant Ophthalmologist-Cornea And Anterior Segment
Principal Investigators
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Wan Haslina Wan Abdul Halim, M.D(UKM)
Role: STUDY_CHAIR
National University of Malaysia
Locations
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UKM Medical Centre
Cheras, Kuala Lumpur, Malaysia
Countries
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Central Contacts
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Facility Contacts
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References
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Jackson TL, Paraskevopoulos T, Georgalas I. Systematic review of 342 cases of endogenous bacterial endophthalmitis. Surv Ophthalmol. 2014 Nov-Dec;59(6):627-35. doi: 10.1016/j.survophthal.2014.06.002. Epub 2014 Jun 18.
Nishida T, Ishida K, Niwa Y, Kawakami H, Mochizuki K, Ohkusu K. An eleven-year retrospective study of endogenous bacterial endophthalmitis. J Ophthalmol. 2015;2015:261310. doi: 10.1155/2015/261310. Epub 2015 Jan 31.
Kernt M, Kampik A. Endophthalmitis: Pathogenesis, clinical presentation, management, and perspectives. Clin Ophthalmol. 2010 Mar 24;4:121-35. doi: 10.2147/opth.s6461.
Puustjarvi T, Terasvirta M, Nurmenniemi P, Lokkila J, Uusitalo H. Penetration of topically applied levofloxacin 0.5% and ofloxacin 0.3% into the vitreous of the non-inflamed human eye. Graefes Arch Clin Exp Ophthalmol. 2006 Dec;244(12):1633-7. doi: 10.1007/s00417-006-0360-0.
Hariprasad SM, Blinder KJ, Shah GK, Apte RS, Rosenblatt B, Holekamp NM, Thomas MA, Mieler WF, Chi J, Prince RA. Penetration pharmacokinetics of topically administered 0.5% moxifloxacin ophthalmic solution in human aqueous and vitreous. Arch Ophthalmol. 2005 Jan;123(1):39-44. doi: 10.1001/archopht.123.1.39.
Robertson SM, Curtis MA, Schlech BA, Rusinko A, Owen GR, Dembinska O, Liao J, Dahlin DC. Ocular pharmacokinetics of moxifloxacin after topical treatment of animals and humans. Surv Ophthalmol. 2005 Nov;50 Suppl 1:S32-45. doi: 10.1016/j.survophthal.2005.07.001.
Bucci FA Jr, Nguimfack IT, Fluet AT. Pharmacokinetics and aqueous humor penetration of levofloxacin 1.5% and moxifloxacin 0.5% in patients undergoing cataract surgery. Clin Ophthalmol. 2016 May 2;10:783-9. doi: 10.2147/OPTH.S91286. eCollection 2016.
Jackson MA, Schutze GE; COMMITTEE ON INFECTIOUS DISEASES. The Use of Systemic and Topical Fluoroquinolones. Pediatrics. 2016 Nov;138(5):e20162706. doi: 10.1542/peds.2016-2706.
Watanabe R, Nakazawa T, Yokokura S, Kubota A, Kubota H, Nishida K. Fluoroquinolone antibacterial eye drops: effects on normal human corneal epithelium, stroma, and endothelium. Clin Ophthalmol. 2010 Oct 21;4:1181-7. doi: 10.2147/OPTH.S13672.
Hanscom TA. Postoperative endophthalmitis. Clin Infect Dis. 2004 Feb 15;38(4):542-6. doi: 10.1086/381262. Epub 2004 Jan 26.
Other Identifiers
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FF-2019-320
Identifier Type: -
Identifier Source: org_study_id
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