| Primary | Number of Participants Without Signs of Anterior Chamber Inflammation | 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%. | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | Posted | | Count of Participants | | Participants | | Day 15 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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 |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| Number of participants without signs | | | Number of participants with signs | |
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| Secondary | Number of Participants With Endophthalmitis | 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. | 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. | Posted | | Count of Participants | | Participants | | Day 4, 8, 15 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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 |
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| Secondary | Number of Participants Without Signs of Anterior Ocular Chamber Inflammation | Number of participants without signs of anterior chamber inflammation (sum of cells and flare score = 0). | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | Posted | | Count of Participants | | Participants | | Day 0 (screening), 4, 8 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Conjunctival Hyperemia | 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). | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | Posted | | Count of Participants | | Participants | | Day 4, 8, 15 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Total Ocular Symptoms Score (TOSS) | 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. | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | Posted | | Mean | Standard Deviation | score on a scale | | Day 4, 8, 15 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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 |
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| Secondary | Ocular Pain/Discomfort: 4-point Scale | Overall ocular pain and discomfort was evaluated by the subject on a 4-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | Posted | | Count of Participants | | Participants | | Day 4, 8, 15 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Use of Rescue Therapy | All rescue therapy used following cataract surgery is to be reported at all visits. | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | Posted | | Count of Participants | | Participants | | During all the treatment until day 15 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Other Pre-specified | Intraocular Pressure (IOP) | IOP is measured using a tonometer. IOP is measured as mmHg; normal intraocular pressures average between 12-22 mm Hg. | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | Posted | | Mean | Standard Deviation | mmHg | | At day 0 (screening) and at day 4, 8, 15 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Other Pre-specified | Visual Acuity | 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. | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | Posted | | Mean | Standard Error | decimal score | | At day 0 (screening) and at day 15 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Other Pre-specified | Adverse Events | 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. | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | Posted | | Count of Participants | | Participants | | During all the treatment until day 15 | | | | ID | Title | Description |
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| OG000 | Levofloxacin + Dexamethasone Followed by Dexamethasone | Levofloxacin 5 mg/ml+Dexamethasone 1 mg/ml (7 days,1 drop/4 times a day) followed by dexamethasone 1 mg/ml (7 days,1 drop/4 times a day). Levofloxacin + dexamethasone followed by dexamethasone: Levofloxacin + dexamethasone ophthalmic solution for 7 days, 1 drop - 4 times a day, followed by dexamethasone ophthalmic suspension (Maxidex®) for an additional 7 days, 1 drop - 4 times a day. | | OG001 | Tobramycin + Dexamethasone | Tobramycin + dexamethasone (14 days, 1 drop/4 times a day). Tobramycin + Dexamethasone: Tobramycin + dexamethasone ophthalmic suspension (Tobradex®) for 14 days, 1 drop - 4 times a day. |
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| Other Pre-specified | Global Evaluation of Local Tolerability | Global evaluation was evaluated on a 4-point scale: 0 = no intolerability, 1 = mild intolerability, 2 = moderate intolerability, 3 = maximum intolerability. | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | Posted | | Mean | Standard Deviation | score on a scale | | Day 4, 8, 15 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Other Pre-specified | Burning, Stinging, Blurred Vision | Burning, stinging, blurred vision were evaluated on a 4-point scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | Posted | | Mean | Standard Deviation | score on a scale | | Day 4, 8, 15 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Other Pre-specified | Assessment of Patient Diary (Compliance) | Treatment compliance is derived from the number of instillations each day during the study treatment exposure | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | Posted | | Count of Participants | | Participants | | Day 15 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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 |
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