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Completed

NCT Number: NCT05213156

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Ophthalmology, General University Hospital of Patras

Pátrai, Achaea, GR26504, Greece

About this study

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connected to a tuberculin syringe, will be inserted into the A/C and approximately 50 μL of aqueous humor will be withdrawn.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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxatrex

Drug

0.3% ofloxacin eye drops in single doses

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. Ocular Surface Disease Index (OSDI)

    Time frame: One day prior to cataract surgery, from 09:00am to 12:00pm

    Scoring of the OSDI questionnaire.

  2. 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.

Sponsors and collaborators

Lead sponsor

University Hospital of Patras

Other

Collaborators

  • University of Patras

Registry information

Official study title

Concentration of Ofloxacin Into the Aqueous Humour of Patients After Topical Instillation According to the Severity of Dry Eye Disease

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2022
Registry last updated
Apr 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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