Concentration of Ofloxacin Into the Aqueous Humour of Patients With Dry Eye Disease
Concentration of Ofloxacin Into the Aqueous Humour of Patients After Topical Instillation According to the Severity of Dry Eye Disease
Study Overview
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connected to a tuberculin syringe, will be inserted into the A/C and approximately 50 μL of aqueous humor will be withdrawn.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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Achaea
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Patras, Achaea, Greece, GR26504
- Department of Ophthalmology, General University Hospital of Patras
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Patients without Dry Eye Disease
Control Group
|
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
|
0.3% ofloxacin eye drops in single doses
|
|
EXPERIMENTAL: Patients with severe Dry Eye Disease
severe Dry Eye Disease
|
0.3% ofloxacin eye drops in single doses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
One day prior to cataract surgery, from 09:00am to 12:00pm
|
|
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.
|
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)
Time Frame: One day prior to cataract surgery, from 09:00am to 12:00pm
|
Scoring of the OSDI questionnaire.
|
One day prior to cataract surgery, from 09:00am to 12:00pm
|
|
Corneal staining
Time Frame: 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.
|
One day prior to cataract surgery, from 09:00am to 12:00pm
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Constantine D. Georgakopoulos, MD, PhD, University Hospital of Patras
Publications and helpful links
General Publications
- Baudouin C, Aragona P, Van Setten G, Rolando M, Irkec M, Benitez del Castillo J, Geerling G, Labetoulle M, Bonini S; ODISSEY European Consensus Group members. Diagnosing the severity of dry eye: a clear and practical algorithm. Br J Ophthalmol. 2014 Sep;98(9):1168-76. doi: 10.1136/bjophthalmol-2013-304619. Epub 2014 Mar 13.
- Perez VL, Stern ME, Pflugfelder SC. Inflammatory basis for dry eye disease flares. Exp Eye Res. 2020 Dec;201:108294. doi: 10.1016/j.exer.2020.108294. Epub 2020 Oct 8.
- Agrahari V, Mandal A, Agrahari V, Trinh HM, Joseph M, Ray A, Hadji H, Mitra R, Pal D, Mitra AK. A comprehensive insight on ocular pharmacokinetics. Drug Deliv Transl Res. 2016 Dec;6(6):735-754. doi: 10.1007/s13346-016-0339-2.
- Barar J, Javadzadeh AR, Omidi Y. Ocular novel drug delivery: impacts of membranes and barriers. Expert Opin Drug Deliv. 2008 May;5(5):567-81. doi: 10.1517/17425247.5.5.567.
- Gatti G, Panozzo G. Effect of inflammation on intraocular penetration of intravenous ofloxacin in albino rabbits. Antimicrob Agents Chemother. 1995 Feb;39(2):549-52. doi: 10.1128/AAC.39.2.549.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1094/31-12-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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