CataractPhase 2iPERMENCT03740659
Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery
A Phase 2 study testing Levofloxacin + Dexamethasone, Levofloxacin and Dexamethasone in people with Cataract, run by NTC srl at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Levofloxacin + Dexamethasone, Levofloxacin and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 2 sitesItaly
- Study dates
- 4 Sep 2018to 6 Dec 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
ASST Santi Paolo e Carlo di Milano - P.O. San Paolo di Milano
Milan, MI, 20142
A.O.U. Pisana - P.O. di Cisanello
Pisa, PI, 56124
About this study
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
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.
Read the 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
- Cataract
- Being tested
- Levofloxacin + Dexamethasone, Levofloxacin, Dexamethasone
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofloxacin + DexamethasoneDrug
Levofloxacin + Dexamethasone ophthalmic solution + dexamethasone 21-phosphate administered twice: 90(±15) min. and 60(±15) min. before limbal paracentesis.
LevofloxacinDrug
Also called Oftaquix®
Levofloxacin ophthalmic solution (Oftaquix®) administered twice: 90 (±15) min. and 60 (±15) min. before limbal paracentesis).
DexamethasoneDrug
Also called Tamesad®
Dexamethasone ophthalmic solution (Tamesad®) administered twice: 90 (±15) min. and 60 (±15) min. before Limbal paracentesis.
| Study group | Role | What they receive |
|---|---|---|
| Levofloxacin + Dexamethasone | Experimental | Levofloxacin 5 mg/ml + Dexamethasone 1 mg/ml (30 μl administered twice before Limbal paracentesis).
Limbal paracentesis will be performed prior to cataract surgery. Receives: Drug: Levofloxacin + Dexamethasone |
| Levofloxacin | Active comparator | Levofloxacin 5 mg/ml (30 μl administered twice before Limbal paracentesis).
Limbal paracentesis will be performed prior to cataract surgery. Receives: Drug: Levofloxacin |
| Dexamethasone | Active comparator | Dexamethasone 1.14 mg/ml (26 μl administered twice before Limbal paracentesis).
Limbal paracentesis will be performed prior to cataract surgery. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 90±15 min after the first administration of the study treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start4 Sep 2018
- Primary completion6 Dec 2018
- Study completion6 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, assessor-blinded, parallel-group study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- NTC srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marco Nardi, Prof., Principal investigator, A.O.U. Pisana - P.O. di Cisanello
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740659
- Sponsor's protocol ID
- LevoDesa_05-2017
- Acronym
- iPERME
- Status last verified
- Jun 2020
- First submitted
- 6 Nov 2018
- Last updated
- 7 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32285142
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03740659
- Acronym / sponsor ID
- iPERME / LevoDesa_05-2017
- Conditions
- Cataract
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- NTC srlIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 6 Dec 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized, assessor-blinded, parallel-group study.
| Arm | Type | Receives |
|---|---|---|
| Levofloxacin + Dexamethasone | Experimental | Drug: Levofloxacin + DexamethasoneLevofloxacin 5 mg/ml + Dexamethasone 1 mg/ml (30 μl administered twice before Limbal paracentesis). Limbal paracentesis will be performed prior to cataract surgery. |
| Levofloxacin | Active comparator | Drug: LevofloxacinLevofloxacin 5 mg/ml (30 μl administered twice before Limbal paracentesis). Limbal paracentesis will be performed prior to cataract surgery. |
| Dexamethasone | Active comparator | Drug: DexamethasoneDexamethasone 1.14 mg/ml (26 μl administered twice before Limbal paracentesis). Limbal paracentesis will be performed prior to cataract surgery. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levofloxacin + DexamethasoneLevofloxacin + Dexamethasone ophthalmic solution + dexamethasone 21-phosphate administered twice: 90(±15) min. and 60(±15) min. before limbal paracentesis. | Drug | Levofloxacin + Dexamethasone |
| LevofloxacinAlso: Oftaquix®Levofloxacin ophthalmic solution (Oftaquix®) administered twice: 90 (±15) min. and 60 (±15) min. before limbal paracentesis). | Drug | Levofloxacin |
| DexamethasoneAlso: Tamesad®Dexamethasone ophthalmic solution (Tamesad®) administered twice: 90 (±15) min. and 60 (±15) min. before Limbal paracentesis. | Drug | Dexamethasone |
Primary outcome
Aqueous Humour Concentration of Levofloxacin
Time frame: 90±15 min after the first administration of the study treatments
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
Time frame: 90±15 min after the first administration of the study treatments
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
Time frame: 90±15 min after the first administration of the study treatments
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32285142Figus 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Nardi, Prof. principal investigator
A.O.U. Pisana - P.O. di Cisanello
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levofloxacin + Dexamethasone, Levofloxacin and Dexamethasone in people with Cataract, run by NTC srl at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aqueous Humour Concentration of Levofloxacin (time frame: 90±15 min after the first administration of the study treatments). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03740659, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.