NCT03739528 (LEADER7) is a Phase 3 clinical trial of Levofloxacin + dexamethasone followed by dexamethasone in Cataract, sponsored by NTC srl.

Who is sponsoring NCT03739528?

NCT03739528 is sponsored by NTC srl.

Is NCT03739528 still recruiting?

NCT03739528 is currently completed. Last updated 18 August 2020.

Are results published for NCT03739528?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-08-18 · How we verify

NCT03739528: LEADER7

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery

Completed Phase 3 Results posted Last updated 18 August 2020

What this trial tests

Phase 3 trial testing Levofloxacin + dexamethasone followed by dexamethasone in Cataract in 808 participants. Completed in 19 December 2018.

Timeline

3 September 2018

Primary endpoint
19 December 2018

19 December 2018

Quick facts

Lead sponsor	NTC srl
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	808
Start date	3 September 2018
Primary completion	19 December 2018
Estimated completion	19 December 2018
Sites	57 locations across Italy

Drugs / interventions tested

Levofloxacin + dexamethasone followed by dexamethasone — full drug profile →
Tobramycin + Dexamethasone — full drug profile →

Conditions studied

Cataract — all drugs for Cataract →

Sponsor

NTC srl — full company profile →

Who can join

40 and older, any sex, with Cataract. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Without Signs of Anterior Chamber Inflammation Primary · 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%.

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	376
Tobramycin + Dexamethasone	373
Levofloxacin + Dexamethasone Followed by Dexamethasone	19
Tobramycin + Dexamethasone	20

Number of Participants With Endophthalmitis Secondary · 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.

Visit 3 - Day 4: no diagnosis of endophthalmitis

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	393
Tobramycin + Dexamethasone	393

Visit 4 - Day 8: no diagnosis of endophthalmitis

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	391
Tobramycin + Dexamethasone	393

Visit 5 - Day 15: no diagnosis of endophthalmitis

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	389
Tobramycin + Dexamethasone	391

Number of Participants Without Signs of Anterior Ocular Chamber Inflammation Secondary · Day 0 (screening), 4, 8

Number of participants without signs of anterior chamber inflammation (sum of cells and flare score = 0).

Visit 1 - Screening

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	395
Tobramycin + Dexamethasone	393
Levofloxacin + Dexamethasone Followed by Dexamethasone	0
Tobramycin + Dexamethasone	0

Visit 3 - Day 4

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	289
Tobramycin + Dexamethasone	302
Levofloxacin + Dexamethasone Followed by Dexamethasone	106
Tobramycin + Dexamethasone	91

Visit 4 - Day 8

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	338
Tobramycin + Dexamethasone	341
Levofloxacin + Dexamethasone Followed by Dexamethasone	57
Tobramycin + Dexamethasone	52

Conjunctival Hyperemia Secondary · 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).

Visit 3 - Day 4

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	337
Tobramycin + Dexamethasone	323
Levofloxacin + Dexamethasone Followed by Dexamethasone	58
Tobramycin + Dexamethasone	70

Visit 4 - Day 8

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	348
Tobramycin + Dexamethasone	358
Levofloxacin + Dexamethasone Followed by Dexamethasone	47
Tobramycin + Dexamethasone	35

Visit 5 - Day 15

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	371
Tobramycin + Dexamethasone	375
Levofloxacin + Dexamethasone Followed by Dexamethasone	24
Tobramycin + Dexamethasone	18

Total Ocular Symptoms Score (TOSS) Secondary · 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.

Visit 3 - Day 4

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	0.29	± 0.63
Tobramycin + Dexamethasone	0.37	± 0.73

Visit 4 - Day 8

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	0.28	± 0.67
Tobramycin + Dexamethasone	0.26	± 0.62

Visit 5 - Day 15

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	0.17	± 0.49
Tobramycin + Dexamethasone	0.17	± 0.59

Ocular Pain/Discomfort: 4-point Scale Secondary · 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).

Visit 3 - Day 4: Presence/absence of ocular pain

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	360
Tobramycin + Dexamethasone	361
Levofloxacin + Dexamethasone Followed by Dexamethasone	35
Tobramycin + Dexamethasone	32

Visit 4 - Day 8: Presence/absence of ocular pain

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	366
Tobramycin + Dexamethasone	366
Levofloxacin + Dexamethasone Followed by Dexamethasone	29
Tobramycin + Dexamethasone	27

Visit 5 - Day 15: Presence/absence of ocular pain

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	377
Tobramycin + Dexamethasone	373
Levofloxacin + Dexamethasone Followed by Dexamethasone	18
Tobramycin + Dexamethasone	20

Use of Rescue Therapy Secondary · During all the treatment until day 15

All rescue therapy used following cataract surgery is to be reported at all visits.

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	392
Tobramycin + Dexamethasone	392
Levofloxacin + Dexamethasone Followed by Dexamethasone	3
Tobramycin + Dexamethasone	1

Intraocular Pressure (IOP) Secondary · 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.

Visit 1 - Screening

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	15.16	± 2.48
Tobramycin + Dexamethasone	15.12	± 2.41

Visit 3 - Day 4

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	14.26	± 2.73
Tobramycin + Dexamethasone	14.49	± 2.81

Visit 4 - Day 8

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	14.29	± 2.51
Tobramycin + Dexamethasone	14.45	± 3.03

Visit 5 - Day 15

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	14.45	± 2.65
Tobramycin + Dexamethasone	14.37	± 2.47

Visual Acuity Secondary · 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 valu

Visit 1 - Screening

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	0.41	± 0.23
Tobramycin + Dexamethasone	0.41	± 0.26

Visit 5 - Day 15

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	0.88	± 0.19
Tobramycin + Dexamethasone	0.89	± 0.17

Adverse Events Secondary · 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.

Patients with TEAEs

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	56
Tobramycin + Dexamethasone	51

Patients with serious TEAEs

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	4
Tobramycin + Dexamethasone	2

Patients with TEAEs suspected to be study related

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	26
Tobramycin + Dexamethasone	26

Patients with TEAEs leading to discontinuation

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	4
Tobramycin + Dexamethasone	3

Patients with fatal TEAEs

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	1
Tobramycin + Dexamethasone	0

Patients with severe TEAEs

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	3
Tobramycin + Dexamethasone	0

Global Evaluation of Local Tolerability Secondary · Day 4, 8, 15

Global evaluation was evaluated on a 4-point scale: 0 = no intolerability, 1 = mild intolerability, 2 = moderate intolerability, 3 = maximum intolerability.

Visit 3 - Day 4

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	0.03	± 0.21
Tobramycin + Dexamethasone	0.01	± 0.09

Visit 4 - Day 8

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	0.01	± 0.11
Tobramycin + Dexamethasone	0.03	± 0.19

Visit 5 - Day 15

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	0.02	± 0.15
Tobramycin + Dexamethasone	0.02	± 0.13

Burning, Stinging, Blurred Vision Secondary · Day 4, 8, 15

Burning, stinging, blurred vision were evaluated on a 4-point scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe.

Burning: visit 3 - day 4

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	0.08	± 0.27
Tobramycin + Dexamethasone	0.09	± 0.29

Burning: visit 4 - day 8

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	0.06	± 0.24
Tobramycin + Dexamethasone	0.11	± 0.35

Burning: visit 5 - day 15

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	0.07	± 0.29
Tobramycin + Dexamethasone	0.07	± 0.27

Stinging: visit 3 - day 4

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	0.05	± 0.23
Tobramycin + Dexamethasone	0.04	± 0.20

Stinging: visit 4 - day 8

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	0.07	± 0.29
Tobramycin + Dexamethasone	0.07	± 0.26

Stinging: visit 5 - day 15

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	0.06	± 0.26
Tobramycin + Dexamethasone	0.04	± 0.20

Blurred vision: visit 3 - day 4

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	0.06	± 0.27
Tobramycin + Dexamethasone	0.05	± 0.23

Blurred vision: visit 4 - day 8

Group	Value	95% CI
Levofloxacin + Dexamethasone Followed by Dexamethasone	0.06	± 0.25
Tobramycin + Dexamethasone	0.04	± 0.22

Adverse events — posted to ClinicalTrials.gov

Time frame: From baseline to the end of the treatment, corresponding to 15 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Levofloxacin + Dexamethasone Followed by Dexamethasone

Serious: 4/388 (1%)

Deaths: 1/395

Tobramycin + Dexamethasone

Serious: 2/388 (1%)

Deaths: 0/393

Serious adverse events (3 terms)

Reaction	System	Levofloxacin + Dexamethaso…	Tobramycin + Dexamethasone
Fall	Injury, poisoning and procedural complications	—	—
Myocardial Infarction	Cardiac disorders	—	—
Retinal Detachment	Eye disorders	—	—

Most-reported serious reactions: Fall, Myocardial Infarction, Retinal Detachment.

Data from ClinicalTrials.gov NCT03739528 adverse events section.

Sponsor's own description

The purpose of this study is to demonstrate the non-inferiority of the study treatment (combined levofloxacin + dexamethasone eye drops) followed by dexamethasone eye drops alone vs. standard treatment in the prevention and treatment of postoperative ocular inflammation and prevention of infection.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Cataract

Currently open trials in the same condition.

NCT07301385 — Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety a · NA · recruiting
NCT07462000 — Aqueous Humor and Ocular Tissue Analysis in Glaucoma and Cataract · NA · recruiting
NCT06891092 — Vivinex Impress XY1-EM vs RayOne EMV · NA · recruiting
NCT07218796 — Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compar · Phase 3 · recruiting
NCT07218783 — Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compar · Phase 3 · recruiting

Other NTC srl trials

Trials by the same sponsor.

NCT07465705 — Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen (CLEARWAY) · Phase 3 · recruiting
NCT06616922 — Assessment of the Effects and Tolerability of RD03/2016 for the Treatment of Bacterial Conjunctivitis in Adults · Phase 2 · completed
NCT04759885 — Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep® · Phase 2, PHASE3 · completed
NCT04676503 — Vaginal and Rectal Colonization of Lactobacillus Crispatus NTCVAG04 Following Oral Administration in Patients With Histo · NA · completed
NCT03740659 — Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Catarac · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03739528 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NTC srl
Last refreshed: 18 August 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03739528.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03739528: LEADER7

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (3 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Cataract

Other NTC srl trials

Verify against primary sources