Trials / Completed
CompletedNCT03740659
Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 125 (actual)
- Sponsor
- NTC srl · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Levofloxacin + Dexamethasone | Levofloxacin + Dexamethasone ophthalmic solution + dexamethasone 21-phosphate administered twice: 90(±15) min. and 60(±15) min. before limbal paracentesis. |
| DRUG | Levofloxacin | Levofloxacin ophthalmic solution (Oftaquix®) administered twice: 90 (±15) min. and 60 (±15) min. before limbal paracentesis). |
| DRUG | Dexamethasone | Dexamethasone ophthalmic solution (Tamesad®) administered twice: 90 (±15) min. and 60 (±15) min. before Limbal paracentesis. |
Timeline
- Start date
- 2018-09-04
- Primary completion
- 2018-12-06
- Completion
- 2018-12-06
- First posted
- 2018-11-14
- Last updated
- 2020-07-07
- Results posted
- 2020-07-07
Locations
2 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT03740659. Inclusion in this directory is not an endorsement.