A Phase 2 interventional study of Levofloxacin + Dexamethasone and Levofloxacin in Cataract, sponsored by NTC srl. Completed at 2 sites in Italy. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2020-07-07.
Sponsored by NTC srl · Phase 2, Interventional, and Other
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.
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 125 is above the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →NTC srl is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 5 mg/ml (30 μl administered twice before Limbal paracentesis). Limbal paracentesis will be performed prior to cataract surgery.
Drug: Levofloxacin
Dexamethasone 1.14 mg/ml (26 μl administered twice before Limbal paracentesis). Limbal paracentesis will be performed prior to cataract surgery.
Drug: Dexamethasone
Levofloxacin + Dexamethasone ophthalmic solution + dexamethasone 21-phosphate administered twice: 90(±15) min. and 60(±15) min. before limbal paracentesis.
Levofloxacin ophthalmic solution (Oftaquix®) administered twice: 90 (±15) min. and 60 (±15) min. before limbal paracentesis).
Also known as: Oftaquix®
Dexamethasone ophthalmic solution (Tamesad®) administered twice: 90 (±15) min. and 60 (±15) min. before Limbal paracentesis.
Also known as: Tamesad®
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.
Time frame: 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.
Time frame: 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.
Time frame: 90±15 min after the first administration of the study treatments
Study Period: * Date of first enrolment: 4 September 2018 * Date study finalized (last patient last visit): 6 December 2018 Study centres: * U.O. Oculistica Universitaria, Azienda Ospedaliera Universitaria Pisana, Presidio Ospedaliero di Cisanello, Pisa; * Clinica Oculistica, Presidio Ospedale San Paolo, Milan.
| Milestone | Levofloxacin + Dexamethasone | Levofloxacin | Dexamethasone |
|---|---|---|---|
| Started | 42 | 42 | 41 |
| Completed | 42 | 42 | 41 |
| Not completed | 0 | 0 | 0 |
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.
| nmol/mL | Levofloxacin + Dexamethasone | Levofloxacin | Dexamethasone |
|---|---|---|---|
| Aqueous Humour Concentration of Levofloxacin | 1.970 (1.648 to 2.292) | 2.151 (1.708 to 2.594) | 0 (0 to 0) |
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.
| nmol/mL | Levofloxacin + Dexamethasone | Levofloxacin | Dexamethasone |
|---|---|---|---|
| Aqueous Humour Concentration of Dexamethasone 21-phosphate | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
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.
| nmol/mL | Levofloxacin + Dexamethasone | Levofloxacin | Dexamethasone |
|---|---|---|---|
| Aqueous Humour Concentration of Dexamethasone | 0.030 (0.025 to 0.035) | 0 (0 to 0) | 0.042 (0.035 to 0.048) |
Collected over From baseline to the study completion, approximately 2 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Levofloxacin + Dexamethasone | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Levofloxacin | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Dexamethasone | 0/41 (0%) | 0/41 (0%) | 1/41 (2.4%) |
| Event | Levofloxacin + Dexamethasone | Levofloxacin | Dexamethasone |
|---|---|---|---|
| Mild MydriasisEye disorders | 0/42 | 0/42 | 1/41 |
Main eligibility criteria included patients of both genders, aged ≥40 years and scheduled for phacoemulsification.
| Age, Categorical(Participants) | Levofloxacin + Dexamethasone | Levofloxacin | Dexamethasone | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 4 | 6 | 17 |
| >=65 years | 35 | 38 | 35 | 108 |
| Age, Continuous(years) | Levofloxacin + Dexamethasone | Levofloxacin | Dexamethasone | Total |
|---|---|---|---|---|
| Mean | 72.45 ± 7.60 | 75.38 ± 8.38 | 74.59 ± 8.00 | 74.14 ± 8.03 |
| Sex: Female, Male(Participants) | Levofloxacin + Dexamethasone | Levofloxacin | Dexamethasone | Total |
|---|---|---|---|---|
| Female | 27 | 21 | 21 | 69 |
| Male | 15 | 21 | 20 | 56 |
| Race (NIH/OMB)(Participants) | Levofloxacin + Dexamethasone | Levofloxacin | Dexamethasone | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 1 |
| White | 42 | 40 | 40 | 122 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Levofloxacin + Dexamethasone | Levofloxacin | Dexamethasone | Total |
|---|---|---|---|---|
| Italy | 42 | 42 | 41 | 125 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NTC srl