Clinical trial NCT05213156: Concentration of Ofloxacin Into the Aqueous Humour of Patients With Dry Eye Disease
Official title: Concentration of Ofloxacin Into the Aqueous Humour of Patients After Topical Instillation According to the Severity of Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Disease
Keywords: Inflammation
Dry Eye Disease
Therapeutics
Topical Application
Aqueous Humour
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
Collaborators: name: University of Patras
First posted: 2022-01-28
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: DED severity
timeFrame: One day prior to cataract surgery, from 09:00am to 12:00pm
measure: Concentration of ofloxacin in the aqueous humour
timeFrame: Beginning of the cataract surgery, from 08:30am to 12:30pm
Secondary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: One day prior to cataract surgery, from 09:00am to 12:00pm
measure: Corneal staining
timeFrame: One day prior to cataract surgery, from 09:00am to 12:00pm
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Department of Ophthalmology, General University Hospital of Patras
state: Achaea
Study officials:
affiliation: University Hospital of Patras
name: Constantine D. Georgakopoulos, MD, PhD
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.