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Completed

NCT Number: NCT03740659

Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery

The purpose of this study is to evaluate the penetration of levofloxacin and dexamethasone 21-phosphate into the aqueous humour after ocular administration in combination or as single active ingredients.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ASST Santi Paolo e Carlo di Milano - P.O. San Paolo di Milano, Milan, MI, Italy

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About this study

In most cases, postoperative care after cataract surgery consists of antiinflammatory and antibacterial drug therapy. The use of an ophthalmic solution containing the combination of a steroid and an antibiotic is routinely used in clinical practice; however, treatment duration could favour the emergence of antibiotic resistance. The study treatment associating a broad-spectrum antibiotic with a highly effective corticosteroid that can be used for a short period of time (one week) is therefore of considerable interest.

The aim of this study is to measure the concentrations of levofloxacin and dexamethasone in the aqueous humour after topical application of the combined ophthalmic solution and its single components.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • Male or female patients, aged ≥40 years
  • Patient undergoing phacoemulsification
  • Corneal thickness between 450 μm and 600 μm as measured by means of pachymetry
  • Corneal integrity confirmed by means of fluorescein test
  • Adequate pupil dilation assessed at screening
  • Female patients of childbearing potential must have a negative pregnancy test
  • Ability to fully understand all study procedures

Exclusion criteria

  • Corneal epithelium integrity not confirmed by fluorescein test
  • History of corneal disease or dystrophy
  • History of ocular trauma with corneal damage
  • History of acute ocular inflammation (including uveitis) in the 6 months prior to screening
  • Previous ocular surgery (including laser treatment)
  • Glaucoma
  • Treatment with an ophthalmic investigational drug in the 3 months prior to screening
  • Treatment with any topical ocular drug within 12 hours before start of cataract surgery other than study drugs and instillation of topical anaesthetic within 10 minutes before start of surgery
  • Treatment with any topical steroid or antibiotic drug in the 7 days prior to cataract surgery
  • Treatment with any systemic steroid or antibiotic drug in the 7 days prior to cataract surgery
  • Known hypersensitivity to levofloxacin, other fluoroquinolones or dexamethasone
  • Pregnant or lactating women
  • Patients who have received any investigational drug during the preceding 30 days or 5 times the plasma half-life, or who have previously participated in this trial

Treatment and study plan

Levofloxacin + Dexamethasone

Drug

Levofloxacin + Dexamethasone ophthalmic solution + dexamethasone 21-phosphate administered twice: 90(±15) min. and 60(±15) min. before limbal paracentesis.

Levofloxacin

Drug

Levofloxacin ophthalmic solution (Oftaquix®) administered twice: 90 (±15) min. and 60 (±15) min. before limbal paracentesis).

Other names: Oftaquix®

Dexamethasone

Drug

Dexamethasone ophthalmic solution (Tamesad®) administered twice: 90 (±15) min. and 60 (±15) min. before Limbal paracentesis.

Other names: Tamesad®

Primary outcomes

  1. Aqueous Humour Concentration of Levofloxacin

    Time frame: 90±15 min after the first administration of the study treatments

    Defined as the concentration of levofloxacin into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin.The concentration of levofloxacin has been measured by LC tandem mass spectrometry.

  2. Aqueous Humour Concentration of Dexamethasone 21-phosphate

    Time frame: 90±15 min after the first administration of the study treatments

    Defined as the concentration of dexamethasone 21-phosphate into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin. The concentration of dexamethasone 21-phosphate has been measured by LC tandem mass spectrometry.

  3. Aqueous Humour Concentration of Dexamethasone

    Time frame: 90±15 min after the first administration of the study treatments

    Defined as the concentration of dexamethasone into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin.The concentration of dexamethasone has been measured by LC tandem mass spectrometry.

Sponsors and collaborators

Lead sponsor

NTC srl

Industry

Registry information

Official study title

Aqueous Humour Concentrations After Topical apPlication of combinEd Levofloxacin-dexamethasone Eye dRops and of Its Single Components: a randoMized, assEssor-blinded, Parallel-group Study in Patients Undergoing Cataract Surgery - iPERME

Acronym: iPERME

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 14, 2018
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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