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

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ClinicalTrials.gov Identifier: NCT03740659
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
NTC srl

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.

Condition or disease Intervention/treatment Phase
Cataract Drug: Levofloxacin + Dexamethasone Drug: Levofloxacin Drug: Dexamethasone Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, assessor-blinded, parallel-group study.
Masking: Single (Outcomes Assessor)
Masking Description: Single
Primary Purpose: Other
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
Actual Study Start Date : September 4, 2018
Actual Primary Completion Date : December 6, 2018
Actual Study Completion Date : December 6, 2018


Arm Intervention/treatment
Experimental: Levofloxacin + Dexamethasone

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

Active Comparator: Levofloxacin

Levofloxacin 5 mg/ml (30 μl administered twice before Limbal paracentesis).

Limbal paracentesis will be performed prior to cataract surgery.

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

Active Comparator: Dexamethasone

Dexamethasone 1.14 mg/ml (26 μl administered twice before Limbal paracentesis).

Limbal paracentesis will be performed prior to cataract surgery.

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




Primary Outcome Measures :
  1. Aqueous humour concentration of levofloxacin [ Time Frame: 90±15 min after the first administration of the study treatments ]
    To evaluate the penetration of levofloxacin into the aqueous humour after ocular administration in combination with dexamethasone or as single active ingredient. The concentration of levofloxacin (mg/ml) will be 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 ]
    To evaluate the penetration of dexamethasone 21-phosphate into the aqueous humour after ocular administration in combination with levofloxacin or as single active ingredient. The concentration of dexamethasone 21-phosphate (mg/ml) will be 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 ]
    To evaluate the penetration of dexamethasone into the aqueous humour after ocular administration in combination with levofloxacin or as single active ingredient. The concentration of dexamethasone (mg/ml) will be measured by LC tandem mass spectrometry.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740659


Locations
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Italy
ASST Santi Paolo e Carlo di Milano - P.O. San Paolo di Milano
Milano, MI, Italy, 20142
A.O.U. Pisana - P.O. di Cisanello
Pisa, PI, Italy, 56124
Sponsors and Collaborators
NTC srl
Investigators
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Principal Investigator: Marco Nardi, Prof. A.O.U. Pisana - P.O. di Cisanello
  Study Documents (Full-Text)

Documents provided by NTC srl:

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Responsible Party: NTC srl
ClinicalTrials.gov Identifier: NCT03740659     History of Changes
Other Study ID Numbers: LevoDesa_05-2017
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Levofloxacin
Ofloxacin
Dexamethasone
Dexamethasone acetate
Ophthalmic Solutions
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmaceutical Solutions
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors