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

Sponsor

University Hospital of Patras (Other)

Overall Status

Completed

CT.gov ID

NCT05213156

Collaborator

University of Patras (Other)

Enrollment

Location

Arms

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: Oxatrex	Phase 4

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connected to a tuberculin syringe, will be inserted into the A/C and approximately 50 μL of aqueous humor will be withdrawn.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

Study Design

Study Type:

Interventional

Actual Enrollment :

91 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

Participants were didvided in three groups: the control group, those who suffer from severe Dry Eye Disease and all other patients with Dry Eye Disease.Participants were didvided in three groups: the control group, those who suffer from severe Dry Eye Disease and all other patients with Dry Eye Disease.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Sep 24, 2019

Actual Primary Completion Date :

Jan 24, 2022

Actual Study Completion Date :

Jan 24, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Patients without Dry Eye Disease Control Group	Drug: Oxatrex 0.3% ofloxacin eye drops in single doses
Experimental: Patients with Dry Eye Disease, except the severe Dry Eye Disease non severe Dry Eye Disease	Drug: Oxatrex 0.3% ofloxacin eye drops in single doses
Experimental: Patients with severe Dry Eye Disease severe Dry Eye Disease	Drug: Oxatrex 0.3% ofloxacin eye drops in single doses

Arm

Intervention/Treatment

Active Comparator: Patients without Dry Eye Disease

Control Group

Drug: Oxatrex

0.3% ofloxacin eye drops in single doses

Experimental: Patients with Dry Eye Disease, except the severe Dry Eye Disease

non severe Dry Eye Disease

Drug: Oxatrex

0.3% ofloxacin eye drops in single doses

Experimental: Patients with severe Dry Eye Disease

severe Dry Eye Disease

Drug: Oxatrex

0.3% ofloxacin eye drops in single doses

Outcome Measures

Primary Outcome Measures

DED severity [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 [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 Outcome Measures

Ocular Surface Disease Index (OSDI) [One day prior to cataract surgery, from 09:00am to 12:00pm]
Scoring of the OSDI questionnaire.
Corneal staining [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.