Dry Eye Disease
Conditions
Keywords
Inflammation, Dry Eye Disease, Therapeutics, Topical Application, Aqueous Humour
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connected to a tuberculin syringe, will be inserted into the A/C and approximately 50 μL of aqueous humor will be withdrawn.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.
Interventions
DRUGOxatrex
0.3% ofloxacin eye drops in single doses
Sponsors
University of Patras
University Hospital of Patras
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SCREENING
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Greece
Outcome results
None listed