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

NCT03740659 | Completed Phase 2 Results

• 1 other identifier: LevoDesa_05-2017
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (3)

• Aqueous Humour Concentration of Levofloxacin

  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.

  90±15 min after the first administration of the study treatments

• Aqueous Humour Concentration of Dexamethasone 21-phosphate

  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.

  90±15 min after the first administration of the study treatments

• Aqueous Humour Concentration of Dexamethasone

  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.

  90±15 min after the first administration of the study treatments

Study Arms (3)

Levofloxacin + Dexamethasone

EXPERIMENTAL

Levofloxacin 5 mg/ml + Dexamethasone 1 mg/ml (30 μl administered twice before Limbal paracentesis). Limbal paracentesis will be performed prior to cataract surgery.

Drug: Levofloxacin + Dexamethasone

Levofloxacin

ACTIVE COMPARATOR

Levofloxacin 5 mg/ml (30 μl administered twice before Limbal paracentesis). Limbal paracentesis will be performed prior to cataract surgery.

Drug: Levofloxacin

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone 1.14 mg/ml (26 μl administered twice before Limbal paracentesis). Limbal paracentesis will be performed prior to cataract surgery.

Drug: Dexamethasone

Interventions

Levofloxacin + Dexamethasone DRUG

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

Levofloxacin + Dexamethasone

Levofloxacin DRUG

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

Also known as: Oftaquix®

Levofloxacin

Dexamethasone DRUG

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

Also known as: Tamesad®

Dexamethasone

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NTC srl: lead

Study Sites (2)

ASST Santi Paolo e Carlo di Milano - P.O. San Paolo di Milano

Milan, MI, 20142, Italy

Location

A.O.U. Pisana - P.O. di Cisanello

Pisa, PI, 56124, Italy

Location

Related Publications (1)

• Figus M, Posarelli C, Romano D, Nardi M, Rossetti L. Aqueous humour concentrations after topical apPlication of combinEd levofloxacin-dexamethasone eye dRops and of its single components: a randoMised, assEssor-blinded, parallel-group study in patients undergoing cataract surgery: the iPERME study. Eur J Clin Pharmacol. 2020 Jul;76(7):929-937. doi: 10.1007/s00228-020-02863-7. Epub 2020 Apr 13.

  PMID: 32285142 DERIVED

MeSH Terms

Conditions

Cataract

Interventions

Levofloxacin; Dexamethasone

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Alessandro Colombo
• Organization: NTC srl

alessandro.colombo@ntcpharma.com

+390243850490

Study Officials

• Marco Nardi, Prof.

  A.O.U. Pisana - P.O. di Cisanello

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, assessor-blinded, parallel-group study.

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 14, 2018
• Study Start: September 4, 2018
• Primary Completion: December 6, 2018
• Study Completion: December 6, 2018
• Last Updated: July 7, 2020
• Results First Posted: July 7, 2020

Record last verified: 2020-06

Locations

IT (2)