Trial Outcomes & Findings for Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery (NCT NCT03739528)
NCT ID: NCT03739528
Last Updated: 2020-08-18
Results Overview
The number of participants without signs of anterior chamber inflammation (sum of cells and flare score = 0). The following non-inferiority hypotheses has been tested: H0 : πT - πS ≤ - Δ; H1 : πT - πS \> - Δ. Where πT and πS are the number of participants without signs of anterior chamber inflammation in the test and standard treatments, respectively, and the non-inferiority margin is Δ = 10%.
COMPLETED
PHASE3
808 participants
Day 15
2020-08-18
Participant Flow
Study period: * Date of first enrolment: 03.09.2018 * Date study finalized (LPLV): 19.12.2018 Study centers: * 42 centers in Italy * 4 centers in Spain * 4 centers in Russia * 1 center in Germany
Planned sample size n.800; randomized patients n.808; screened patients n.863
Participant milestones
| Measure |
Levofloxacin + Dexamethasone Followed by Dexamethasone
Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)
Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day.
|
Tobramycin + Dexamethasone
Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)
Dose and regimen: 1 drop - 4 times a day for 14 days
|
|---|---|---|
|
Overall Study
STARTED
|
403
|
405
|
|
Overall Study
Received at Least One Treatment
|
395
|
393
|
|
Overall Study
COMPLETED
|
388
|
388
|
|
Overall Study
NOT COMPLETED
|
15
|
17
|
Reasons for withdrawal
| Measure |
Levofloxacin + Dexamethasone Followed by Dexamethasone
Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)
Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day.
|
Tobramycin + Dexamethasone
Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)
Dose and regimen: 1 drop - 4 times a day for 14 days
|
|---|---|---|
|
Overall Study
Not treated
|
8
|
12
|
|
Overall Study
Treatment and study discontinued
|
6
|
2
|
|
Overall Study
Treatment discontinued + study completed
|
1
|
3
|
Baseline Characteristics
Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery
Baseline characteristics by cohort
| Measure |
Levofloxacin + Dexamethasone Followed by Dexamethasone
n=395 Participants
Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)
Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day.
|
Tobramycin + Dexamethasone
n=393 Participants
Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)
Dose and regimen: 1 drop - 4 times a day for 14 days
|
Total
n=788 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=93 Participants
|
71 Participants
n=4 Participants
|
141 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
325 Participants
n=93 Participants
|
322 Participants
n=4 Participants
|
647 Participants
n=27 Participants
|
|
Age, Continuous
|
72.12 years
STANDARD_DEVIATION 8.55 • n=93 Participants
|
71.84 years
STANDARD_DEVIATION 8.64 • n=4 Participants
|
71.98 years
STANDARD_DEVIATION 8.59 • n=27 Participants
|
|
Sex: Female, Male
Female
|
229 Participants
n=93 Participants
|
239 Participants
n=4 Participants
|
468 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
166 Participants
n=93 Participants
|
154 Participants
n=4 Participants
|
320 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
393 Participants
n=93 Participants
|
391 Participants
n=4 Participants
|
784 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set)
The number of participants without signs of anterior chamber inflammation (sum of cells and flare score = 0). The following non-inferiority hypotheses has been tested: H0 : πT - πS ≤ - Δ; H1 : πT - πS \> - Δ. Where πT and πS are the number of participants without signs of anterior chamber inflammation in the test and standard treatments, respectively, and the non-inferiority margin is Δ = 10%.
Outcome measures
| Measure |
Levofloxacin + Dexamethasone Followed by Dexamethasone
n=395 Participants
Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)
Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day.
|
Tobramycin + Dexamethasone
n=393 Participants
Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)
Dose and regimen: 1 drop - 4 times a day for 14 days
|
|---|---|---|
|
Number of Participants Without Signs of Anterior Chamber Inflammation
Number of participants with signs
|
19 Participants
|
20 Participants
|
|
Number of Participants Without Signs of Anterior Chamber Inflammation
Number of participants without signs
|
376 Participants
|
373 Participants
|
SECONDARY outcome
Timeframe: Day 4, 8, 15Population: The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set). This outcome was not analyzed by applying the Last Observation Carried Forward (LOCF) method to impute missing values if at least one post-baseline value was available.
The number of participants with endophthalmitis after administration of study treatment in the study was assessed and reported. Diagnosis of endophthalmitis is based on clinical evaluation of signs and symptoms (such as swollen eyelids, ocular pain, conjunctival hyperemia, decreased visual acuity, opaque vitreous) through slit lamp examination, and microbiological tests on conjunctival or corneal swabs.
Outcome measures
| Measure |
Levofloxacin + Dexamethasone Followed by Dexamethasone
n=395 Participants
Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)
Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day.
|
Tobramycin + Dexamethasone
n=393 Participants
Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)
Dose and regimen: 1 drop - 4 times a day for 14 days
|
|---|---|---|
|
Number of Participants With Endophthalmitis
Visit 3 - Day 4: no diagnosis of endophthalmitis
|
393 Participants
|
393 Participants
|
|
Number of Participants With Endophthalmitis
Visit 4 - Day 8: no diagnosis of endophthalmitis
|
391 Participants
|
393 Participants
|
|
Number of Participants With Endophthalmitis
Visit 5 - Day 15: no diagnosis of endophthalmitis
|
389 Participants
|
391 Participants
|
SECONDARY outcome
Timeframe: Day 0 (screening), 4, 8Population: The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set)
Number of participants without signs of anterior chamber inflammation (sum of cells and flare score = 0).
Outcome measures
| Measure |
Levofloxacin + Dexamethasone Followed by Dexamethasone
n=395 Participants
Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)
Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day.
|
Tobramycin + Dexamethasone
n=393 Participants
Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)
Dose and regimen: 1 drop - 4 times a day for 14 days
|
|---|---|---|
|
Number of Participants Without Signs of Anterior Ocular Chamber Inflammation
Visit 1 - Screening · Number of participants without signs
|
395 Participants
|
393 Participants
|
|
Number of Participants Without Signs of Anterior Ocular Chamber Inflammation
Visit 1 - Screening · Number of participants with signs
|
0 Participants
|
0 Participants
|
|
Number of Participants Without Signs of Anterior Ocular Chamber Inflammation
Visit 3 - Day 4 · Number of participants without signs
|
289 Participants
|
302 Participants
|
|
Number of Participants Without Signs of Anterior Ocular Chamber Inflammation
Visit 3 - Day 4 · Number of participants with signs
|
106 Participants
|
91 Participants
|
|
Number of Participants Without Signs of Anterior Ocular Chamber Inflammation
Visit 4 - Day 8 · Number of participants without signs
|
338 Participants
|
341 Participants
|
|
Number of Participants Without Signs of Anterior Ocular Chamber Inflammation
Visit 4 - Day 8 · Number of participants with signs
|
57 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: Day 4, 8, 15Population: The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set)
Conjunctival hyperemia was evaluated with slit lamp and results provided as a score as follows: 0 = absence of inflammation, 1 = mild inflammation (some vessels injected), 2 = moderate inflammation (diffuse injection of vessels, but individual vessels are still discernable) 3 = severe inflammation (intense injection of vessels, individual vessels not easily discernable).
Outcome measures
| Measure |
Levofloxacin + Dexamethasone Followed by Dexamethasone
n=395 Participants
Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)
Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day.
|
Tobramycin + Dexamethasone
n=393 Participants
Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)
Dose and regimen: 1 drop - 4 times a day for 14 days
|
|---|---|---|
|
Conjunctival Hyperemia
Visit 3 - Day 4 · Score=0
|
337 Participants
|
323 Participants
|
|
Conjunctival Hyperemia
Visit 3 - Day 4 · Score>0
|
58 Participants
|
70 Participants
|
|
Conjunctival Hyperemia
Visit 4 - Day 8 · Score=0
|
348 Participants
|
358 Participants
|
|
Conjunctival Hyperemia
Visit 4 - Day 8 · Score>0
|
47 Participants
|
35 Participants
|
|
Conjunctival Hyperemia
Visit 5 - Day 15 · Score=0
|
371 Participants
|
375 Participants
|
|
Conjunctival Hyperemia
Visit 5 - Day 15 · Score>0
|
24 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 4, 8, 15Population: The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set)
The TOSS is a patient-reported evaluation in the TOSS Questionnaire of 3 ocular symptoms: itching/burning, hyperemia of conjunctiva and tearing. A score was given in the presence of symptoms: 0 = none, 1 = mild, 2 = moderate, 3 = severe.
Outcome measures
| Measure |
Levofloxacin + Dexamethasone Followed by Dexamethasone
n=395 Participants
Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)
Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day.
|
Tobramycin + Dexamethasone
n=393 Participants
Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)
Dose and regimen: 1 drop - 4 times a day for 14 days
|
|---|---|---|
|
Total Ocular Symptoms Score (TOSS)
Visit 3 - Day 4
|
0.29 score on a scale
Standard Deviation 0.63
|
0.37 score on a scale
Standard Deviation 0.73
|
|
Total Ocular Symptoms Score (TOSS)
Visit 4 - Day 8
|
0.28 score on a scale
Standard Deviation 0.67
|
0.26 score on a scale
Standard Deviation 0.62
|
|
Total Ocular Symptoms Score (TOSS)
Visit 5 - Day 15
|
0.17 score on a scale
Standard Deviation 0.49
|
0.17 score on a scale
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: Day 4, 8, 15Population: The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set)
Overall ocular pain and discomfort was evaluated by the subject on a 4-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe).
Outcome measures
| Measure |
Levofloxacin + Dexamethasone Followed by Dexamethasone
n=395 Participants
Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)
Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day.
|
Tobramycin + Dexamethasone
n=393 Participants
Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)
Dose and regimen: 1 drop - 4 times a day for 14 days
|
|---|---|---|
|
Ocular Pain/Discomfort: 4-point Scale
Visit 3 - Day 4: Presence/absence of ocular pain · Score=0
|
360 Participants
|
361 Participants
|
|
Ocular Pain/Discomfort: 4-point Scale
Visit 3 - Day 4: Presence/absence of ocular pain · Score>0
|
35 Participants
|
32 Participants
|
|
Ocular Pain/Discomfort: 4-point Scale
Visit 4 - Day 8: Presence/absence of ocular pain · Score=0
|
366 Participants
|
366 Participants
|
|
Ocular Pain/Discomfort: 4-point Scale
Visit 4 - Day 8: Presence/absence of ocular pain · Score>0
|
29 Participants
|
27 Participants
|
|
Ocular Pain/Discomfort: 4-point Scale
Visit 5 - Day 15: Presence/absence of ocular pain · Score=0
|
377 Participants
|
373 Participants
|
|
Ocular Pain/Discomfort: 4-point Scale
Visit 5 - Day 15: Presence/absence of ocular pain · Score>0
|
18 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: During all the treatment until day 15Population: The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set)
All rescue therapy used following cataract surgery is to be reported at all visits.
Outcome measures
| Measure |
Levofloxacin + Dexamethasone Followed by Dexamethasone
n=395 Participants
Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)
Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day.
|
Tobramycin + Dexamethasone
n=393 Participants
Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)
Dose and regimen: 1 drop - 4 times a day for 14 days
|
|---|---|---|
|
Use of Rescue Therapy
Patients with rescue therapy
|
392 Participants
|
392 Participants
|
|
Use of Rescue Therapy
Patients with no rescue therapy
|
3 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At day 0 (screening) and at day 4, 8, 15Population: The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set)
IOP is measured using a tonometer. IOP is measured as mmHg; normal intraocular pressures average between 12-22 mm Hg.
Outcome measures
| Measure |
Levofloxacin + Dexamethasone Followed by Dexamethasone
n=395 Participants
Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)
Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day.
|
Tobramycin + Dexamethasone
n=393 Participants
Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)
Dose and regimen: 1 drop - 4 times a day for 14 days
|
|---|---|---|
|
Intraocular Pressure (IOP)
Visit 3 - Day 4
|
14.26 mmHg
Standard Deviation 2.73
|
14.49 mmHg
Standard Deviation 2.81
|
|
Intraocular Pressure (IOP)
Visit 4 - Day 8
|
14.29 mmHg
Standard Deviation 2.51
|
14.45 mmHg
Standard Deviation 3.03
|
|
Intraocular Pressure (IOP)
Visit 1 - Screening
|
15.16 mmHg
Standard Deviation 2.48
|
15.12 mmHg
Standard Deviation 2.41
|
|
Intraocular Pressure (IOP)
Visit 5 - Day 15
|
14.45 mmHg
Standard Deviation 2.65
|
14.37 mmHg
Standard Deviation 2.47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At day 0 (screening) and at day 15Population: The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set)
Visual acuity was assessed as per local clinical practice, i.e. with the Snellen (feet) or the ETDRS (meter) chart. Visual acuity was then analysed using decimal unit. Decimal score is the decimal expression of the Snellen (feet) or the ETDRS (meter) charts in which the numerator indicates the distance from the chart and the denominator indicates the size of the smallest line that can be read. Decimal values were provided directly from the investigator or computed as a result of the Snellen or ETDRS fraction. Generally decimal values from 0.01 to 0.10 indicate severe vision loss; decimal values from 0.125 to 0.25 indicate moderate vision loss; decimal values from 0.32 to 0.63 indicate mild vision loss; decimal values from 0.8 to 1.6 indicate normal vision. Lower decimal values correspond to a reduced visual acuity and worst outcomes, while higher decimal values indicate an improved visual acuity and better outcomes.
Outcome measures
| Measure |
Levofloxacin + Dexamethasone Followed by Dexamethasone
n=395 Participants
Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)
Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day.
|
Tobramycin + Dexamethasone
n=393 Participants
Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)
Dose and regimen: 1 drop - 4 times a day for 14 days
|
|---|---|---|
|
Visual Acuity
Visit 1 - Screening
|
0.41 decimal score
Standard Error 0.23
|
0.41 decimal score
Standard Error 0.26
|
|
Visual Acuity
Visit 5 - Day 15
|
0.88 decimal score
Standard Error 0.19
|
0.89 decimal score
Standard Error 0.17
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During all the treatment until day 15Population: The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set)
Adverse events were described according to System Organ Classes (SOC) and Preferred Terms (PT) using the Medical Dictionary for Regulatory Activities (MedDRA) and were presented by treatment group.
Outcome measures
| Measure |
Levofloxacin + Dexamethasone Followed by Dexamethasone
n=395 Participants
Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)
Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day.
|
Tobramycin + Dexamethasone
n=393 Participants
Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)
Dose and regimen: 1 drop - 4 times a day for 14 days
|
|---|---|---|
|
Adverse Events
Patients with serious TEAEs
|
4 Participants
|
2 Participants
|
|
Adverse Events
Patients with TEAEs suspected to be study related
|
26 Participants
|
26 Participants
|
|
Adverse Events
Patients with TEAEs leading to discontinuation
|
4 Participants
|
3 Participants
|
|
Adverse Events
Patients with fatal TEAEs
|
1 Participants
|
0 Participants
|
|
Adverse Events
Patients with severe TEAEs
|
3 Participants
|
0 Participants
|
|
Adverse Events
Patients with TEAEs
|
56 Participants
|
51 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 4, 8, 15Population: The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set)
Global evaluation was evaluated on a 4-point scale: 0 = no intolerability, 1 = mild intolerability, 2 = moderate intolerability, 3 = maximum intolerability.
Outcome measures
| Measure |
Levofloxacin + Dexamethasone Followed by Dexamethasone
n=395 Participants
Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)
Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day.
|
Tobramycin + Dexamethasone
n=393 Participants
Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)
Dose and regimen: 1 drop - 4 times a day for 14 days
|
|---|---|---|
|
Global Evaluation of Local Tolerability
Visit 3 - Day 4
|
0.03 score on a scale
Standard Deviation 0.21
|
0.01 score on a scale
Standard Deviation 0.09
|
|
Global Evaluation of Local Tolerability
Visit 4 - Day 8
|
0.01 score on a scale
Standard Deviation 0.11
|
0.03 score on a scale
Standard Deviation 0.19
|
|
Global Evaluation of Local Tolerability
Visit 5 - Day 15
|
0.02 score on a scale
Standard Deviation 0.15
|
0.02 score on a scale
Standard Deviation 0.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 4, 8, 15Population: The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set)
Burning, stinging, blurred vision were evaluated on a 4-point scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe.
Outcome measures
| Measure |
Levofloxacin + Dexamethasone Followed by Dexamethasone
n=395 Participants
Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)
Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day.
|
Tobramycin + Dexamethasone
n=393 Participants
Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)
Dose and regimen: 1 drop - 4 times a day for 14 days
|
|---|---|---|
|
Burning, Stinging, Blurred Vision
Burning: visit 3 - day 4
|
0.08 score on a scale
Standard Deviation 0.27
|
0.09 score on a scale
Standard Deviation 0.29
|
|
Burning, Stinging, Blurred Vision
Burning: visit 4 - day 8
|
0.06 score on a scale
Standard Deviation 0.24
|
0.11 score on a scale
Standard Deviation 0.35
|
|
Burning, Stinging, Blurred Vision
Burning: visit 5 - day 15
|
0.07 score on a scale
Standard Deviation 0.29
|
0.07 score on a scale
Standard Deviation 0.27
|
|
Burning, Stinging, Blurred Vision
Stinging: visit 3 - day 4
|
0.05 score on a scale
Standard Deviation 0.23
|
0.04 score on a scale
Standard Deviation 0.20
|
|
Burning, Stinging, Blurred Vision
Stinging: visit 4 - day 8
|
0.07 score on a scale
Standard Deviation 0.29
|
0.07 score on a scale
Standard Deviation 0.26
|
|
Burning, Stinging, Blurred Vision
Stinging: visit 5 - day 15
|
0.06 score on a scale
Standard Deviation 0.26
|
0.04 score on a scale
Standard Deviation 0.20
|
|
Burning, Stinging, Blurred Vision
Blurred vision: visit 3 - day 4
|
0.06 score on a scale
Standard Deviation 0.27
|
0.05 score on a scale
Standard Deviation 0.23
|
|
Burning, Stinging, Blurred Vision
Blurred vision: visit 4 - day 8
|
0.06 score on a scale
Standard Deviation 0.25
|
0.04 score on a scale
Standard Deviation 0.22
|
|
Burning, Stinging, Blurred Vision
Blurred vision: visit 5 - day 15
|
0.03 score on a scale
Standard Deviation 0.20
|
0.01 score on a scale
Standard Deviation 0.11
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 15Population: The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set)
Treatment compliance is derived from the number of instillations each day during the study treatment exposure
Outcome measures
| Measure |
Levofloxacin + Dexamethasone Followed by Dexamethasone
n=395 Participants
Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)
Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day.
|
Tobramycin + Dexamethasone
n=393 Participants
Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)
Dose and regimen: 1 drop - 4 times a day for 14 days
|
|---|---|---|
|
Assessment of Patient Diary (Compliance)
One missed dose per day or three missed doses per
|
59 Participants
|
57 Participants
|
|
Assessment of Patient Diary (Compliance)
No missed dose
|
332 Participants
|
332 Participants
|
|
Assessment of Patient Diary (Compliance)
> 1 missed dose per day or > 3 missed doses per we
|
4 Participants
|
4 Participants
|
Adverse Events
Levofloxacin + Dexamethasone Followed by Dexamethasone
Tobramycin + Dexamethasone
Serious adverse events
| Measure |
Levofloxacin + Dexamethasone Followed by Dexamethasone
n=395 participants at risk；n=388 participants at risk
Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)
Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day.
|
Tobramycin + Dexamethasone
n=393 participants at risk；n=388 participants at risk
Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)
Dose and regimen: 1 drop - 4 times a day for 14 days
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.26%
1/388 • Number of events 1 • From baseline to the end of the treatment, corresponding to 15 days
It is not possible to attribute Adverse Events to Dexamethasone alone following treatment with Levofloxacin + Dexamethasone
|
0.26%
1/388 • Number of events 1 • From baseline to the end of the treatment, corresponding to 15 days
It is not possible to attribute Adverse Events to Dexamethasone alone following treatment with Levofloxacin + Dexamethasone
|
|
Eye disorders
Retinal Detachment
|
0.26%
1/388 • Number of events 1 • From baseline to the end of the treatment, corresponding to 15 days
It is not possible to attribute Adverse Events to Dexamethasone alone following treatment with Levofloxacin + Dexamethasone
|
0.00%
0/388 • From baseline to the end of the treatment, corresponding to 15 days
It is not possible to attribute Adverse Events to Dexamethasone alone following treatment with Levofloxacin + Dexamethasone
|
|
Injury, poisoning and procedural complications
Fall
|
0.52%
2/388 • Number of events 2 • From baseline to the end of the treatment, corresponding to 15 days
It is not possible to attribute Adverse Events to Dexamethasone alone following treatment with Levofloxacin + Dexamethasone
|
0.26%
1/388 • Number of events 1 • From baseline to the end of the treatment, corresponding to 15 days
It is not possible to attribute Adverse Events to Dexamethasone alone following treatment with Levofloxacin + Dexamethasone
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place