Concentration of Ofloxacin Into the Aqueous Humour of Patients With Dry Eye Disease

Dry Eye Disease Clinical Trial

Official title:

Concentration of Ofloxacin Into the Aqueous Humour of Patients After Topical Instillation According to the Severity of Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05213156
• Other study ID #: 1094/31-12-18
• Status: Completed
• Phase: Phase 4
• Start date: September 24, 2019
• Est. completion date: January 24, 2022

Study information

• Verified date: April 2022
• Source: University Hospital of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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connected to a tuberculin syringe, will be inserted into the A/C and approximately 50 μL of aqueous humor will be withdrawn.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 24, 2022
• Est. primary completion date: January 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 < 20?

• 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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Oxatrex
0.3% ofloxacin eye drops in single doses

Locations

Country	Name	City	State
Greece	Department of Ophthalmology, General University Hospital of Patras	Patras	Achaea

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Patras	University of Patras

Country where clinical trial is conducted

Greece, 

References & Publications (7)

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. Review. — View 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 . Review. — View Citation

Baudouin C, Aragona P, Van Setten G, Rolando M, Irkeç M, Benítez 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. — View 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. — View Citation

Oztürk 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. — View Citation

Oztürk 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DED severity	DED severity will be determined during preoperative cataract evaluation.	One day prior to cataract surgery, from 09:00am to 12:00pm
Primary	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.	Beginning of the cataract surgery, from 08:30am to 12:30pm
Secondary	Ocular Surface Disease Index (OSDI)	Scoring of the OSDI questionnaire.	One day prior to cataract surgery, from 09:00am to 12:00pm
Secondary	Corneal staining	?valuation of ocular surface damage by corneal fluorescein staining using the Oxford scale.	One day prior to cataract surgery, from 09:00am to 12:00pm