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

NCT05213156 | Completed Phase 4

• 1 other identifier: 1094/31-12-18
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease

Keywords

Inflammation; Dry Eye Disease; Therapeutics; Topical Application; Aqueous Humour

Outcome Measures

Primary Outcomes (2)

• DED severity

  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

  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 Outcomes (2)

• Ocular Surface Disease Index (OSDI)

  One day prior to cataract surgery, from 09:00am to 12:00pm

• Corneal staining

  One day prior to cataract surgery, from 09:00am to 12:00pm

Study Arms (3)

Patients without Dry Eye Disease

ACTIVE COMPARATOR

Control Group

Drug: Oxatrex

Patients with Dry Eye Disease, except the severe Dry Eye Disease

EXPERIMENTAL

non severe Dry Eye Disease

Drug: Oxatrex

Patients with severe Dry Eye Disease

EXPERIMENTAL

severe Dry Eye Disease

Drug: Oxatrex

Interventions

Oxatrex DRUG

0.3% ofloxacin eye drops in single doses

Patients with Dry Eye Disease, except the severe Dry Eye Disease; Patients with severe Dry Eye Disease; Patients without Dry Eye Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cataract surgery
• willing to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Patras: lead
• University of Patras: collaborator

Study Sites (1)

Department of Ophthalmology, General University Hospital of Patras

Pátrai, Achaea, GR26504, Greece

Location

Related Publications (7)

• 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.

  PMID: 24627252 BACKGROUND

• 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.

  PMID: 33039458 BACKGROUND

• 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.

  PMID: 27798766 BACKGROUND

• 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.

  PMID: 18491982 BACKGROUND

• 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.

  PMID: 7726531 BACKGROUND

• 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.

  PMID: 10550786 BACKGROUND

• 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.

  PMID: 11011990 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes; Inflammation

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Constantine D. Georgakopoulos, MD, PhD

  University Hospital of Patras

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Ophthalmology

Model Details: 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.

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 28, 2022
• Study Start: September 24, 2019
• Primary Completion: January 24, 2022
• Study Completion: January 24, 2022
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)