Concentration of Ofloxacin Into the Aqueous Humour of Patients After Topical Instillation According to the Severity of Dry Eye Disease
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 91
- Locations
- 1
- Primary Endpoint
- DED severity
Study Overview
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connected to a tuberculin syringe, will be inserted into the A/C and approximately 50 μL of aqueous humor will be withdrawn.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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Screening
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Exclusion Criteria
- Not provided
Arms & Interventions
Patients without Dry Eye Disease
Control Group
Intervention: Oxatrex (Drug)
Patients with Dry Eye Disease, except the severe Dry Eye Disease
non severe Dry Eye Disease
Intervention: Oxatrex (Drug)
Patients with severe Dry Eye Disease
severe Dry Eye Disease
Intervention: Oxatrex (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Corneal staining(One day prior to cataract surgery, from 09:00am to 12:00pm)
- Ocular Surface Disease Index (OSDI)(One day prior to cataract surgery, from 09:00am to 12:00pm)
Investigators
Constantinos D. Georgakopoulos, MD, PhD
Associate Professor in Ophthalmology
University Hospital of Patras