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

Primary Purpose

Cataract

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Levofloxacin + Dexamethasone
Levofloxacin
Dexamethasone
Sponsored by
NTC srl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cataract

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Corneal epithelium integrity not confirmed by fluorescein test
  2. History of corneal disease or dystrophy
  3. History of ocular trauma with corneal damage
  4. History of acute ocular inflammation (including uveitis) in the 6 months prior to screening
  5. Previous ocular surgery (including laser treatment)
  6. Glaucoma
  7. Treatment with an ophthalmic investigational drug in the 3 months prior to screening
  8. 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
  9. Treatment with any topical steroid or antibiotic drug in the 7 days prior to cataract surgery
  10. Treatment with any systemic steroid or antibiotic drug in the 7 days prior to cataract surgery
  11. Known hypersensitivity to levofloxacin, other fluoroquinolones or dexamethasone
  12. Pregnant or lactating women
  13. 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

Sites / Locations

  • ASST Santi Paolo e Carlo di Milano - P.O. San Paolo di Milano
  • A.O.U. Pisana - P.O. di Cisanello

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Levofloxacin + Dexamethasone

Levofloxacin

Dexamethasone

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 6, 2018
Last Updated
June 19, 2020
Sponsor
NTC srl
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1. Study Identification

Unique Protocol Identification Number
NCT03740659
Brief Title
Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery
Acronym
iPERME
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 4, 2018 (Actual)
Primary Completion Date
December 6, 2018 (Actual)
Study Completion Date
December 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NTC srl

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A randomized, assessor-blinded, parallel-group study.
Masking
Outcomes Assessor
Masking Description
Single
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levofloxacin + Dexamethasone
Arm Type
Experimental
Arm Description
Levofloxacin 5 mg/ml + Dexamethasone 1 mg/ml (30 μl administered twice before Limbal paracentesis). Limbal paracentesis will be performed prior to cataract surgery.
Arm Title
Levofloxacin
Arm Type
Active Comparator
Arm Description
Levofloxacin 5 mg/ml (30 μl administered twice before Limbal paracentesis). Limbal paracentesis will be performed prior to cataract surgery.
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Dexamethasone 1.14 mg/ml (26 μl administered twice before Limbal paracentesis). Limbal paracentesis will be performed prior to cataract surgery.
Intervention Type
Drug
Intervention Name(s)
Levofloxacin + Dexamethasone
Intervention Description
Levofloxacin + Dexamethasone ophthalmic solution + dexamethasone 21-phosphate administered twice: 90(±15) min. and 60(±15) min. before limbal paracentesis.
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Other Intervention Name(s)
Oftaquix®
Intervention Description
Levofloxacin ophthalmic solution (Oftaquix®) administered twice: 90 (±15) min. and 60 (±15) min. before limbal paracentesis).
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Tamesad®
Intervention Description
Dexamethasone ophthalmic solution (Tamesad®) administered twice: 90 (±15) min. and 60 (±15) min. before Limbal paracentesis.
Primary Outcome Measure Information:
Title
Aqueous Humour Concentration of Levofloxacin
Description
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.
Time Frame
90±15 min after the first administration of the study treatments
Title
Aqueous Humour Concentration of Dexamethasone 21-phosphate
Description
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.
Time Frame
90±15 min after the first administration of the study treatments
Title
Aqueous Humour Concentration of Dexamethasone
Description
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.
Time Frame
90±15 min after the first administration of the study treatments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Nardi, Prof.
Organizational Affiliation
A.O.U. Pisana - P.O. di Cisanello
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASST Santi Paolo e Carlo di Milano - P.O. San Paolo di Milano
City
Milano
State/Province
MI
ZIP/Postal Code
20142
Country
Italy
Facility Name
A.O.U. Pisana - P.O. di Cisanello
City
Pisa
State/Province
PI
ZIP/Postal Code
56124
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
32285142
Citation
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.
Results Reference
derived

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

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