Trials Sponsors Conditions Drugs Pricing

Conditions

Conjunctivitis, Bacterial

Keywords

RD03/2016Levofloxacin

Outcome Measures

Primary Outcomes (1)

Proportion of patients with microbiological eradication
Absence/no growth of pathogenic microorganisms or reduction below pathogenic criteria of opportunistic microorganisms susceptible to levofloxacin identified at baseline, as assessed through bacteriological culture and antibiotic susceptibility testing at the final visit (Day 7-9).
At the Final visit (Day 7-9)

Secondary Outcomes (6)

By-pathogen microbiological eradication rate of levofloxacin-susceptible bacteria
At baseline that are eradicated at the final visit (Day 7-9)
Overall per-patient microbiological eradication rate of bacteria intermediate or resistant to levofloxacin
At the final visit (Day 7-9)
Overall by-pathogen microbiological eradication rate of bacteria intermediate or resistant to levofloxacin
At baseline that are eradicated at the final visit (Day 7-9)
Proportion of patients with clinical cure
At Day 3-4 and final visit (Day 7-9)
Time to clinical cure
Every 12 ± 1 hours from Day 0 to Day 7-9
+1 more secondary outcomes

Other Outcomes (9)

Safety: Adverse events throughout the study
Throughout the study, from Day 0 to Day 7-9
Local tolerability: Ocular itching/burning or discomfort related to study drug instillation
Twice a day, from Day 0 to Day 5
Compliance: Assessment of the number of instillations
From Day 1 to Day 5
+6 more other outcomes

Study Arms (2)

Test arm

EXPERIMENTAL

Patients will be randomly assigned (1:1) to one of the two treatment groups

Drug: RD03/2016 eye drops

Standard drug arm

ACTIVE COMPARATOR

Patients will be randomly assigned (1:1) to one of the two treatment groups

Drug: Levofloxacin 0.5% eye drops solution (Oftaquix®)

Interventions

RD03/2016 eye dropsDrug

1 drop, 4 times a day (approximately every 4 hours while awake) for 5 days starting from Day 1.

Also known as: Levofloxacin + Ketorolac Trometamol 0.5+0.5% w/v eye drops solution

Test arm

Levofloxacin 0.5% eye drops solution (Oftaquix®)Drug

1 drop, 8 times a day (approximately every 2 hours while awake) on Days 1 and 2, and 1 drop, 4 times a day (approximately every 4 hours while awake) on Days 3 through 5.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ability of patient to consent and provide signed written informed consent
Male or female aged ≥ 18 year.

Sponsors & Collaborators

NTC srl
Industrylead

Study Sites (41)

Städtisches Klinikum Karlsruhe Augenklinik

Karlsruhe, Germany

A.O.U. Policlinico Consorziale di Bari

Bari, Italy

ASST Papa Giovanni XXIII

Bergamo, Italy

Ospedale della Versilia

Camaiore, Italy

Centro Polispecialistico Achille Sicari

Carrara, Italy

Presidio Ospedaliero G. Rodolico - A.O.U. "Policlinico - Vittorio Emanuele"

Catania, Italy

ASST Franciacorta - Ospedale di Chiari

Chiari, Italy

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

LevofloxacinOphthalmic Solutions

Condition Hierarchy (Ancestors)

Eye Infections, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsEye InfectionsConjunctivitisConjunctival DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones

Study Officials

Francesco Bandello, Prof.
Ospedale San Raffaele IRCCS S.r.l.
PRINCIPAL INVESTIGATOR

Enrollment

252 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 20, 2024

First Posted

September 27, 2024

Study Start

November 5, 2021

Actual (reported)

Assessment of the Effects and Tolerability of RD03/2016 for the Treatment of Bacterial Conjunctivitis in Adults

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Other Outcomes (9)

Study Arms (2)

Test arm

Standard drug arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (41)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Other Outcomes (9)

Study Arms (2)

Test arm

Standard drug arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (41)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations