Trial · NCT03739528
Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery
NCT03739528, Phase 3, Completed, NTC srl; results first posted 2020-08-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery. Trials, record NCT03739528. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03739528
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery
- NCT number
- NCT03739528
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 808 participants, actual
- Lead sponsor
- NTC srl
- Conditions
- Cataract
- Interventions
- Levofloxacin + dexamethasone followed by dexamethasone, Tobramycin + Dexamethasone
- First posted
- 2018-11-14
- Last updated
- 2020-08-18
- Results first posted
- 2020-08-18
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Without Signs of Anterior Chamber Inflammation | Day 15 | 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%. |
| Secondary | Number of Participants With Endophthalmitis | Day 4, 8, 15 | 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. |
| Secondary | Number of Participants Without Signs of Anterior Ocular Chamber Inflammation | Day 0 (screening), 4, 8 | Number of participants without signs of anterior chamber inflammation (sum of cells and flare score = 0). |
| Secondary | Conjunctival Hyperemia | Day 4, 8, 15 | 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). |
| Secondary | Total Ocular Symptoms Score (TOSS) | Day 4, 8, 15 | 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. |
| Secondary | Ocular Pain/Discomfort: 4-point Scale | Day 4, 8, 15 | Overall ocular pain and discomfort was evaluated by the subject on a 4-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). |
| Secondary | Use of Rescue Therapy | During all the treatment until day 15 | All rescue therapy used following cataract surgery is to be reported at all visits. |
| Other | Intraocular Pressure (IOP) | At day 0 (screening) and at day 4, 8, 15 | IOP is measured using a tonometer. IOP is measured as mmHg; normal intraocular pressures average between 12-22 mm Hg. |
| Other | Visual Acuity | At day 0 (screening) and at day 15 | 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. |
| Other | Adverse Events | During all the treatment until day 15 | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Without Signs of Anterior Chamber Inflammation | Day 15 | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Endophthalmitis | Day 4, 8, 15 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Without Signs of Anterior Ocular Chamber Inflammation | Day 0 (screening), 4, 8 | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Conjunctival Hyperemia | Day 4, 8, 15 | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Total Ocular Symptoms Score (TOSS) | Day 4, 8, 15 | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | score on a scale | MEAN |
| SECONDARY | Ocular Pain/Discomfort: 4-point Scale | Day 4, 8, 15 | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Use of Rescue Therapy | During all the treatment until day 15 | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Intraocular Pressure (IOP) | At day 0 (screening) and at day 4, 8, 15 | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | mmHg | MEAN |
| OTHER_PRE_SPECIFIED | Visual Acuity | At day 0 (screening) and at day 15 | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | decimal score | MEAN |
| OTHER_PRE_SPECIFIED | Adverse Events | During all the treatment until day 15 | The analysis population is represented by all randomized patients who received at least one dose of study treatment (Full Analysis Set) | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group110
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Without Signs of Anterior Chamber Inflammation | Levofloxacin + Dexamethasone Followed by Dexamethasone | Number of participants without signs | 376 | Participants | |
| Number of Participants Without Signs of Anterior Chamber Inflammation | Tobramycin + Dexamethasone | Number of participants without signs | 373 | Participants | |
| Number of Participants Without Signs of Anterior Chamber Inflammation | Levofloxacin + Dexamethasone Followed by Dexamethasone | Number of participants with signs | 19 | Participants | |
| Number of Participants Without Signs of Anterior Chamber Inflammation | Tobramycin + Dexamethasone | Number of participants with signs | 20 | Participants | |
| Number of Participants With Endophthalmitis | Levofloxacin + Dexamethasone Followed by Dexamethasone | Visit 3 - Day 4: no diagnosis of endophthalmitis | 393 | Participants | |
| Number of Participants With Endophthalmitis | Tobramycin + Dexamethasone | Visit 3 - Day 4: no diagnosis of endophthalmitis | 393 | Participants | |
| Number of Participants With Endophthalmitis | Levofloxacin + Dexamethasone Followed by Dexamethasone | Visit 4 - Day 8: no diagnosis of endophthalmitis | 391 | Participants | |
| Number of Participants With Endophthalmitis | Tobramycin + Dexamethasone | Visit 4 - Day 8: no diagnosis of endophthalmitis | 393 | Participants | |
| Number of Participants With Endophthalmitis | Levofloxacin + Dexamethasone Followed by Dexamethasone | Visit 5 - Day 15: no diagnosis of endophthalmitis | 389 | Participants | |
| Number of Participants With Endophthalmitis | Tobramycin + Dexamethasone | Visit 5 - Day 15: no diagnosis of endophthalmitis | 391 | Participants |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Levofloxacin + Dexamethasone Followed by Dexamethasone | 403 | |
| Overall Study | STARTED | Tobramycin + Dexamethasone | 405 | |
| Overall Study | Received at Least One Treatment | Levofloxacin + Dexamethasone Followed by Dexamethasone | 395 | |
| Overall Study | Received at Least One Treatment | Tobramycin + Dexamethasone | 393 | |
| Overall Study | COMPLETED | Levofloxacin + Dexamethasone Followed by Dexamethasone | 388 | |
| Overall Study | COMPLETED | Tobramycin + Dexamethasone | 388 | |
| Overall Study | NOT COMPLETED | Levofloxacin + Dexamethasone Followed by Dexamethasone | 15 | |
| Overall Study | NOT COMPLETED | Tobramycin + Dexamethasone | 17 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Myocardial Infarction | Cardiac disorders | Levofloxacin + Dexamethasone Followed by Dexamethasone | 1 | 388 | 1 |
| serious | Myocardial Infarction | Cardiac disorders | Tobramycin + Dexamethasone | 1 | 388 | 1 |
| serious | Retinal Detachment | Eye disorders | Levofloxacin + Dexamethasone Followed by Dexamethasone | 1 | 388 | 1 |
| serious | Retinal Detachment | Eye disorders | Tobramycin + Dexamethasone | 0 | 388 | 0 |
| serious | Fall | Injury, poisoning and procedural complications | Levofloxacin + Dexamethasone Followed by Dexamethasone | 2 | 388 | 2 |
| serious | Fall | Injury, poisoning and procedural complications | Tobramycin + Dexamethasone | 1 | 388 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levofloxacin + Dexamethasone Followed by Dexamethasone | 1 | 395 |
| Total, all-cause mortality | Tobramycin + Dexamethasone | 0 | 393 |
| Total, other adverse events | Levofloxacin + Dexamethasone Followed by Dexamethasone | 0 | 395 |
| Total, other adverse events | Tobramycin + Dexamethasone | 0 | 393 |
| Total, serious adverse events | Levofloxacin + Dexamethasone Followed by Dexamethasone | 4 | 388 |
| Total, serious adverse events | Tobramycin + Dexamethasone | 2 | 388 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Levofloxacin + Dexamethasone Followed by Dexamethasone vs Tobramycin + Dexamethasone: deaths from any cause | Trial comparisons |
| Levofloxacin + Dexamethasone Followed by Dexamethasone vs Tobramycin + Dexamethasone: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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