Trial Outcomes & Findings for Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery (NCT NCT03740659)
NCT ID: NCT03740659
Last Updated: 2020-07-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
125 participants
Primary outcome timeframe
90±15 min after the first administration of the study treatments
Results posted on
2020-07-07
Participant Flow
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.
Planned sample size n.120; randomized patients n.125; screened patients n.133 (1 patient screened for both eyes).
Participant milestones
| Measure |
Levofloxacin + Dexamethasone
Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone.
Administration route: ocular instillation
Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP).
|
Levofloxacin
Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin.
Administration route: ocular instillation
Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin).
|
Dexamethasone
Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone.
Administration route: ocular instillation
Dose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP).
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
41
|
|
Overall Study
COMPLETED
|
42
|
42
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery
Baseline characteristics by cohort
| Measure |
Levofloxacin + Dexamethasone
n=42 Participants
Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone.
Administration route: ocular instillation
Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP).
|
Levofloxacin
n=42 Participants
Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin.
Administration route: ocular instillation
Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin).
|
Dexamethasone
n=41 Participants
Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone.
Administration route: ocular instillation
Dose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP).
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Age, Continuous
|
72.45 years
STANDARD_DEVIATION 7.60 • n=5 Participants
|
75.38 years
STANDARD_DEVIATION 8.38 • n=7 Participants
|
74.59 years
STANDARD_DEVIATION 8.00 • n=5 Participants
|
74.14 years
STANDARD_DEVIATION 8.03 • n=4 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
42 participants
n=5 Participants
|
42 participants
n=7 Participants
|
41 participants
n=5 Participants
|
125 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 90±15 min after the first administration of the study treatmentsPopulation: Participants in all Arms/Groups were assessed for this Outcome Measure regardless of treatment type
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.
Outcome measures
| Measure |
Levofloxacin + Dexamethasone
n=42 Participants
Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone.
Administration route: ocular instillation
Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP).
|
Levofloxacin
n=42 Participants
Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin.
Administration route: ocular instillation
Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin).
|
Dexamethasone
n=41 Participants
Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone.
Administration route: ocular instillation
Dose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP).
|
|---|---|---|---|
|
Aqueous Humour Concentration of Levofloxacin
|
1.970 nmol/mL
Interval 1.648 to 2.292
|
2.151 nmol/mL
Interval 1.708 to 2.594
|
0 nmol/mL
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: 90±15 min after the first administration of the study treatmentsPopulation: Participants in all Arms/Groups were assessed for this Outcome Measure regardless of treatment type
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.
Outcome measures
| Measure |
Levofloxacin + Dexamethasone
n=42 Participants
Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone.
Administration route: ocular instillation
Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP).
|
Levofloxacin
n=42 Participants
Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin.
Administration route: ocular instillation
Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin).
|
Dexamethasone
n=41 Participants
Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone.
Administration route: ocular instillation
Dose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP).
|
|---|---|---|---|
|
Aqueous Humour Concentration of Dexamethasone 21-phosphate
|
0 nmol/mL
Interval 0.0 to 0.0
|
0 nmol/mL
Interval 0.0 to 0.0
|
0 nmol/mL
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: 90±15 min after the first administration of the study treatmentsPopulation: Participants in all Arms/Groups were assessed for this Outcome Measure regardless of treatment type
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.
Outcome measures
| Measure |
Levofloxacin + Dexamethasone
n=42 Participants
Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone.
Administration route: ocular instillation
Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP).
|
Levofloxacin
n=42 Participants
Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin.
Administration route: ocular instillation
Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin).
|
Dexamethasone
n=41 Participants
Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone.
Administration route: ocular instillation
Dose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP).
|
|---|---|---|---|
|
Aqueous Humour Concentration of Dexamethasone
|
0.030 nmol/mL
Interval 0.025 to 0.035
|
0 nmol/mL
Interval 0.0 to 0.0
|
0.042 nmol/mL
Interval 0.035 to 0.048
|
Adverse Events
Levofloxacin + Dexamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Levofloxacin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexamethasone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Levofloxacin + Dexamethasone
n=42 participants at risk
Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone.
Administration route: ocular instillation
Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP).
|
Levofloxacin
n=42 participants at risk
Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin.
Administration route: ocular instillation
Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin).
|
Dexamethasone
n=41 participants at risk
Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone.
Administration route: ocular instillation
Dose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP).
|
|---|---|---|---|
|
Eye disorders
Mild Mydriasis
|
0.00%
0/42 • From baseline to the study completion, approximately 2 hours
|
0.00%
0/42 • From baseline to the study completion, approximately 2 hours
|
2.4%
1/41 • Number of events 1 • From baseline to the study completion, approximately 2 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER