Concentration of Ofloxacin Into the Aqueous Humour of Patients With Dry Eye Disease
NCT ID: NCT05213156
Last Updated: 2022-04-18
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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COMPLETED
PHASE4
91 participants
INTERVENTIONAL
2019-09-24
2022-01-24
Brief Summary
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Detailed Description
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The day before cataract surgery will be performed patient examination, during standard cataract preoperative evaluation. Briefly, symptom-based assessment will be delivered by scoring the Ocular Surface Disease Index (OSDI) questionnaire, and evaluation of ocular surface damage will be performed by corneal fluorescein staining using the Oxford scale.
Before surgery, patients will be assigned to receive one drop of commercially available topical ofloxacin solution 0.3% at monodoses without preservatives (Oxatrex, Zwitter Pharmaceuticals, Greece) four times at fifteen minutes intervals starting 2 hours before surgery. The eye drops will be applied in the middle of the inferior lower fornix. Patients who miss any of the 4 doses will be excluded from the study. Aqueous humor will be collected after 1 hour of the last administration, intraoperatively, at the beginning of cataract surgery.
A paracentesis track will be made with a 15ᵒ superblade, a 30G cannula, connected to a tuberculin syringe, will be inserted into the A/C and approximately 50 μL of aqueous humor will be withdrawn. AqH samples will be collected in an Eppendorf tube. All samples will kept frozen at -20ᵒC.
Ofloxacin concentrations will be determined by HPLC-MS/MS.
DED severity, symptoms (Ocular Surface Disease Index) and signs (corneal staining using the Oxford score) will be correlated to ofloxacin's concentration in the AqH.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SCREENING
QUADRUPLE
Study Groups
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Patients without Dry Eye Disease
Control Group
Oxatrex
0.3% ofloxacin eye drops in single doses
Patients with Dry Eye Disease, except the severe Dry Eye Disease
non severe Dry Eye Disease
Oxatrex
0.3% ofloxacin eye drops in single doses
Patients with severe Dry Eye Disease
severe Dry Eye Disease
Oxatrex
0.3% ofloxacin eye drops in single doses
Interventions
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Oxatrex
0.3% ofloxacin eye drops in single doses
Eligibility Criteria
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Inclusion Criteria
* willing to participate
Exclusion Criteria
* pigment dispersion syndrome
* anterior chamber angle \< 20ᵒ
* other ocular pathology than cataract
* abnormal eyelid function
* diabetes mellitus, renal or hepatic failure
* chronic topical ocular treatment
* systematic antibiotic treatment
* allergy to fluoroquinolone antibiotics
* contact lens use
18 Years
ALL
Yes
Sponsors
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University of Patras
OTHER
University Hospital of Patras
OTHER
Responsible Party
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Constantinos D. Georgakopoulos, MD, PhD
Associate Professor in Ophthalmology
Principal Investigators
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Constantine D. Georgakopoulos, MD, PhD
Role: STUDY_DIRECTOR
University Hospital of Patras
Locations
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Department of Ophthalmology, General University Hospital of Patras
Pátrai, Achaea, Greece
Countries
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References
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Baudouin C, Aragona P, Van Setten G, Rolando M, Irkec M, Benitez del Castillo J, Geerling G, Labetoulle M, Bonini S; ODISSEY European Consensus Group members. Diagnosing the severity of dry eye: a clear and practical algorithm. Br J Ophthalmol. 2014 Sep;98(9):1168-76. doi: 10.1136/bjophthalmol-2013-304619. Epub 2014 Mar 13.
Perez VL, Stern ME, Pflugfelder SC. Inflammatory basis for dry eye disease flares. Exp Eye Res. 2020 Dec;201:108294. doi: 10.1016/j.exer.2020.108294. Epub 2020 Oct 8.
Agrahari V, Mandal A, Agrahari V, Trinh HM, Joseph M, Ray A, Hadji H, Mitra R, Pal D, Mitra AK. A comprehensive insight on ocular pharmacokinetics. Drug Deliv Transl Res. 2016 Dec;6(6):735-754. doi: 10.1007/s13346-016-0339-2.
Barar J, Javadzadeh AR, Omidi Y. Ocular novel drug delivery: impacts of membranes and barriers. Expert Opin Drug Deliv. 2008 May;5(5):567-81. doi: 10.1517/17425247.5.5.567.
Gatti G, Panozzo G. Effect of inflammation on intraocular penetration of intravenous ofloxacin in albino rabbits. Antimicrob Agents Chemother. 1995 Feb;39(2):549-52. doi: 10.1128/AAC.39.2.549.
Ozturk F, Kortunay S, Kurt E, Inan UU, Ilker SS, Basci N, Bozkurt A. The effect of long-term use and inflammation on the ocular penetration of topical ofloxacin. Curr Eye Res. 1999 Dec;19(6):461-4. doi: 10.1076/ceyr.19.6.461.5277.
Ozturk F, Kurt E, Inan UU, Kortunay MC, Ilker SS, Basci NE, Bozkurt A. Penetration of topical and oral ofloxacin into the aqueous and vitreous humor of inflamed rabbit eyes. Int J Pharm. 2000 Aug 25;204(1-2):91-5. doi: 10.1016/s0378-5173(00)00482-8.
Other Identifiers
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1094/31-12-18
Identifier Type: -
Identifier Source: org_study_id
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