Concentration of Ofloxacin Into the Aqueous Humour of Patients With Dry Eye Disease
Primary Purpose
Dry Eye Disease
Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Oxatrex
Sponsored by
About this trial
This is an interventional screening trial for Dry Eye Disease focused on measuring Inflammation, Dry Eye Disease, Therapeutics, Topical Application, Aqueous Humour
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
Sites / Locations
- Department of Ophthalmology, General University Hospital of Patras
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Patients without Dry Eye Disease
Patients with Dry Eye Disease, except the severe Dry Eye Disease
Patients with severe Dry Eye Disease
Arm Description
Control Group
non severe Dry Eye Disease
severe Dry Eye Disease
Outcomes
Primary Outcome Measures
DED severity
DED severity will be determined during preoperative cataract evaluation.
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.
Secondary Outcome Measures
Ocular Surface Disease Index (OSDI)
Scoring of the OSDI questionnaire.
Corneal staining
Εvaluation of ocular surface damage by corneal fluorescein staining using the Oxford scale.
Full Information
NCT ID
NCT05213156
First Posted
December 23, 2021
Last Updated
April 14, 2022
Sponsor
University Hospital of Patras
Collaborators
University of Patras
1. Study Identification
Unique Protocol Identification Number
NCT05213156
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 24, 2019 (Actual)
Primary Completion Date
January 24, 2022 (Actual)
Study Completion Date
January 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Patras
Collaborators
University of Patras
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
Keywords
Inflammation, Dry Eye Disease, Therapeutics, Topical Application, Aqueous Humour
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients without Dry Eye Disease
Arm Type
Active Comparator
Arm Description
Control Group
Arm Title
Patients with Dry Eye Disease, except the severe Dry Eye Disease
Arm Type
Experimental
Arm Description
non severe Dry Eye Disease
Arm Title
Patients with severe Dry Eye Disease
Arm Type
Experimental
Arm Description
severe Dry Eye Disease
Intervention Type
Drug
Intervention Name(s)
Oxatrex
Intervention Description
0.3% ofloxacin eye drops in single doses
Primary Outcome Measure Information:
Title
DED severity
Description
DED severity will be determined during preoperative cataract evaluation.
Time Frame
One day prior to cataract surgery, from 09:00am to 12:00pm
Title
Concentration of ofloxacin in the aqueous humour
Description
After topical instillation of ofloxacin eye drops, aqueous humor samples will be collected intraoperatively and ofloxacin concentration will be determined by HPLC-MS/MS.
Time Frame
Beginning of the cataract surgery, from 08:30am to 12:30pm
Secondary Outcome Measure Information:
Title
Ocular Surface Disease Index (OSDI)
Description
Scoring of the OSDI questionnaire.
Time Frame
One day prior to cataract surgery, from 09:00am to 12:00pm
Title
Corneal staining
Description
Εvaluation of ocular surface damage by corneal fluorescein staining using the Oxford scale.
Time Frame
One day prior to cataract surgery, from 09:00am to 12:00pm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constantine D. Georgakopoulos, MD, PhD
Organizational Affiliation
University Hospital of Patras
Official's Role
Study Director
Facility Information:
Facility Name
Department of Ophthalmology, General University Hospital of Patras
City
Patras
State/Province
Achaea
ZIP/Postal Code
GR26504
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24627252
Citation
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.
Results Reference
background
PubMed Identifier
33039458
Citation
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.
Results Reference
background
PubMed Identifier
27798766
Citation
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.
Results Reference
background
PubMed Identifier
18491982
Citation
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.
Results Reference
background
PubMed Identifier
7726531
Citation
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.
Results Reference
background
PubMed Identifier
10550786
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.
Results Reference
background
PubMed Identifier
11011990
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.
Results Reference
background
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Concentration of Ofloxacin Into the Aqueous Humour of Patients With Dry Eye Disease
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