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Dry Eye DiseasePhase 4NCT05213156

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

A Phase 4 study testing Oxatrex in people with Dry Eye Disease, run by University Hospital of Patras at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dry Eye Disease
What is being tested?
Oxatrex
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
1 siteGreece
Study dates
24 Sep 2019to 24 Jan 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • cataract surgery
  • willing to participate

Who cannot join

  • 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
Show all 10Show fewer
  • chronic topical ocular treatment
  • systematic antibiotic treatment
  • allergy to fluoroquinolone antibiotics
  • contact lens use

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Department of Ophthalmology, General University Hospital of Patras

    Pátrai, Achaea, GR26504

Other trials in Greece

About this study

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

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.

Read the 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.

Conditions
Dry Eye Disease
Being tested
Oxatrex
Keywords
Inflammation, Dry Eye Disease, Therapeutics, Topical Application, Aqueous Humour
Medical subject headings
Dry Eye Syndromes, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxatrexDrug

    0.3% ofloxacin eye drops in single doses

Study groups in NCT05213156
Study groupRoleWhat they receive
Patients without Dry Eye DiseaseActive comparatorControl Group
Receives: Drug: Oxatrex
Patients with Dry Eye Disease, except the severe Dry Eye DiseaseExperimentalnon severe Dry Eye Disease
Receives: Drug: Oxatrex
Patients with severe Dry Eye DiseaseExperimentalsevere Dry Eye Disease
Receives: Drug: Oxatrex

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DED severity

    DED severity will be determined during preoperative cataract evaluation.

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

  2. 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.

    Measured: Beginning of the cataract surgery, from 08:30am to 12:30pm

Secondary outcomes (2)

  1. Ocular Surface Disease Index (OSDI)

    Scoring of the OSDI questionnaire.

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

  2. Corneal staining

    Εvaluation of ocular surface damage by corneal fluorescein staining using the Oxford scale.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2022
  2. Study start24 Sep 2019
  3. Primary completion24 Jan 2022
  4. Study completion24 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Screening
Allocation
Randomised
Intervention model
Factorial
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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05213156
Sponsor's protocol ID
1094/31-12-18
Status last verified
Apr 2022
First submitted
23 Dec 2021
Last updated
18 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 24627252

  • 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.

    PubMed 33039458

  • 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.

    PubMed 27798766

  • 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.

    PubMed 18491982

  • 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.

    PubMed 7726531

  • 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.

    PubMed 10550786

  • 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.

    PubMed 11011990

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oxatrex in people with Dry Eye Disease, run by University Hospital of Patras at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DED severity (time frame: One day prior to cataract surgery, from 09:00am to 12:00pm). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05213156, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.

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