Phase 2
Completed N=125
Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery
Source: ClinicalTrials.gov NCT03740659 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Aqueous Humour Concentration of Levofloxacin — 1.970; 2.151; 0 nmol/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aqueous Humour Concentration of Levofloxacin |
1.970; 2.151; 0 | — |
| PRIMARY Aqueous Humour Concentration of Dexamethasone 21-phosphate |
0; 0; 0 | — |
| PRIMARY Aqueous Humour Concentration of Dexamethasone |
0.030; 0; 0.042 | — |
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
Data sourced from ClinicalTrials.gov (NCT03740659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.