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

Study Overview
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Brief Summary
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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.

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connected to a tuberculin syringe, will be inserted into the A/C and approximately 50 μL of aqueous humor will be withdrawn.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

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

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: Oxatrex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, Dry Eye Disease, Therapeutics, Topical Application, Aqueous Humour