Concentration of Ofloxacin Into the Aqueous Humour of Patients With Dry Eye Disease

Overview

After topical installation of one drop of 0.3% commercially available ofloxacin (Oxatrex®) four times at intervals of 15min in catarract patients with Dry Eye Disease, aqueous humour samples will be collected intraoperatively, one hour after the last installation. Concentration of ofloxacin in aqueous humour will be measured by HPLC-MS/MS.

Full Title of Study: “Concentration of Ofloxacin Into the Aqueous Humour of Patients After Topical Instillation According to the Severity of Dry Eye Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Screening
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 24, 2022

Detailed Description

Patients will be categorized into three Groups, according to DED severity. Group I comprises of subjects without DED, Group II of patients are evaluated as non-severe DED, and Group III consists of patients suffering from severe DED. 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connected to a tuberculin syringe, will be inserted into the A/C and approximately 50 μL of aqueous humor will be withdrawn.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.

Interventions

  • Drug: Oxatrex
    • 0.3% ofloxacin eye drops in single doses

Arms, Groups and Cohorts

  • Active Comparator: Patients without Dry Eye Disease
    • Control Group
  • Experimental: Patients with Dry Eye Disease, except the severe Dry Eye Disease
    • non severe Dry Eye Disease
  • Experimental: Patients with severe Dry Eye Disease
    • severe Dry Eye Disease

Clinical Trial Outcome Measures

Primary Measures

  • DED severity
    • Time Frame: One day prior to cataract surgery, from 09:00am to 12:00pm
    • DED severity will be determined during preoperative cataract evaluation.
  • Concentration of ofloxacin in the aqueous humour
    • Time Frame: Beginning of the cataract surgery, from 08:30am to 12:30pm
    • After topical instillation of ofloxacin eye drops, aqueous humor samples will be collected intraoperatively and ofloxacin concentration will be determined by HPLC-MS/MS.

Secondary Measures

  • Ocular Surface Disease Index (OSDI)
    • Time Frame: One day prior to cataract surgery, from 09:00am to 12:00pm
    • Scoring of the OSDI questionnaire.
  • Corneal staining
    • Time Frame: One day prior to cataract surgery, from 09:00am to 12:00pm
    • Εvaluation of ocular surface damage by corneal fluorescein staining using the Oxford scale.

Participating in This Clinical Trial

Inclusion Criteria

  • cataract surgery – willing to participate Exclusion criteria:

  • presence of exfoliation material within the anterior segment of the eye – 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital of Patras
  • Collaborator
    • University of Patras
  • Provider of Information About this Clinical Study
    • Principal Investigator: Constantinos D. Georgakopoulos, MD, PhD, Associate Professor in Ophthalmology – University Hospital of Patras
  • Overall Official(s)
    • Constantine D. Georgakopoulos, MD, PhD, Study Director, University Hospital of Patras

References

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.

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