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

NCT06616922 | Completed Phase 2

• 1 other identifier: LEVOKETO_02-2020
• Study Type: interventional
• Target: 252
• Locations: 4 countries
• Sites: 41

Brief Summary

This is a phase II, randomized, parallel-group, blinded-assessor, multicentre study to assess the non-inferiority of RD03/2016 eye drops vs. levofloxacin eye drops alone (1:1) in microbiological eradication in patients with a clinical diagnosis of bacterial conjunctivitis with moderate/severe signs.

Conditions

Conjunctivitis, Bacterial

Keywords

RD03/2016; Levofloxacin

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

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

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 drops DRUG

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.

Also known as: Oftaquix® 5 mg/ml eye drops solution

Standard drug arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• Clinical diagnosis of acute bacterial conjunctivitis with moderate/severe signs (score ≥ 2 for each cardinal signs, i.e. bulbar conjunctival injection, palpebral conjunctival injection and conjunctival discharge, in at least one eye), not previously treated with antibiotics, steroids and nonsteroidal anti-inflammatory drugs (NSAIDs).
• Able and willing to follow study procedures.
• Availability of a person (a relative or a caregiver) to be trained for the execution of the photographic documentation required by the study and for the use of eyePRO.net.
• Willing to interrupt the use of contact lenses for the entire duration of the study.

You may not qualify if:

• Any acute ocular clinical disease other than bacterial conjunctivitis.
• Any ocular surgery (including laser treatment) in the study eye within 30 days prior to study entry.
• Any ocular (in the study eye) or systemic antimicrobial agents administered concurrently or within 3 days prior to study entry.
• Any ocular (in the study eye) or systemic steroids or NSAIDs administered concurrently.
• Pathological conditions or treatments that in the opinion of the Investigator may interfere with the efficacy and/or safety evaluations of the study (e.g. chronic blepharitis, glaucoma, moderate-severe dry eye).
• Participation in previous clinical studies if less than 5 half-lives of the Investigational Medicinal Product (IMP) used have passed.
• Hypersensitivity to the products, other quinolones, acetylsalicylic acid and other NSAIDs (due to potential for cross-sensitivity), or their excipients.
• Contraindications to ocular treatment with levofloxacin and/or ketorolac.
• Pregnancy or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at baseline visit and practice effective contraceptive measures throughout the study.

Sponsors & Collaborators

• NTC srl: lead

Study Sites (41)

Städtisches Klinikum Karlsruhe Augenklinik

Karlsruhe, Germany

Location

A.O.U. Policlinico Consorziale di Bari

Bari, Italy

Location

ASST Papa Giovanni XXIII

Bergamo, Italy

Location

Ospedale della Versilia

Camaiore, Italy

Location

Centro Polispecialistico Achille Sicari

Carrara, Italy

Location

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

Catania, Italy

Location

ASST Franciacorta - Ospedale di Chiari

Chiari, Italy

Location

Clinica Oftalmologica Ospedale SS Annunziata

Chieti, Italy

Location

Clinica Oculistica Azienda Ospedaliero-Universitaria Careggi di Firenze

Florence, Italy

Location

Clinica Oculistica Azienda Ospedaliero - Universitaria Policlinico "G. Martino"

Messina, Italy

Location

ASST Fatebenefratelli Sacco - Istituto Fatebenefratelli e Oftalmico

Milan, Italy

Location

ASST Fatebenefratelli Sacco

Milan, Italy

Location

ASST Santi Carlo e Paolo

Milan, Italy

Location

Clinica Oculistica Ospedale San Giuseppe

Milan, Italy

Location

Ospedale Maggiore Policlinico - U.O. Oculistica Fondazione IRCCS Ca' Granda

Milan, Italy

Location

Oculistica Ospedale G. Fogliani

Milazzo, Italy

Location

U.O.S.C. Oculistica Az. Osp. di Rilievo Nazionale A. Cardarelli

Napoli, Italy

Location

A.O.U. Policlinico P. Giaccone

Palermo, Italy

Location

ARNAS Civico Di Cristina Benfratelli

Palermo, Italy

Location

Presidio Ospedaliero di Cisanello - Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Location

Azienda Ospedaliera Sant'Andrea

Roma, Italy

Location

Fondazione Policlinico Universitario - IRCSS Agostino Gemelli

Roma, Italy

Location

IRCCS Fondazione G.B. Bietti

Roma, Italy

Location

IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Location

S.S. Annunziata di Savigliano

Savigliano, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, Italy

Location

Ospedale di Treviso, AULSS2 Treviso

Treviso, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

Location

Regional Budgetary Institution of Healthcare "Ivanovo Regional Clinical Hospital"

Ivanovo, Russia

Location

Federal State Autonomous Institution "S.N. Fedorov National Medical Research Center "MNTK "Eye Microsurgery" of the Ministry of Health of the Russian Federation

Moscow, Russia

Location

Federal State Budgetary Educational Institution of High Professional Education "Moscow State Medical Stomatology University named after A.I.Evdokimov"

Moscow, Russia

Location

State Budgetary Institution "National Medical Research Center for Eye Diseases named after Helmholts" of the Ministry of Healthcare of the Russian Federation

Moscow, Russia

Location

State Budgetary Healthcare Institution of the Omsk Region "Clinical Ophthalmological Hospital named after V.P. Vykhodtsev"

Omsk, Russia

Location

LLC Sphera-Med

Saint Petersburg, Russia

Location

Private Institution of Healthcare "Clinical hospital "RR-Medicine" of the city of Saint-Petersburg"

Saint Petersburg, Russia

Location

State Budgetary Healthcare Institution of Yaroslavl Region "Clinical Hospital #2"

Yaroslavl, Russia

Location

Sección De Cornea, Hospital Universitario La Paz

Madrid, Spain

Location

Ophthalmology Unit Empresa Pública Hospital Costa del Sol

Marbella, Spain

Location

Hospital La Fe Avenida de Fernando Abril Martorell

Valencia, Spain

Location

Servicio De Oftalmología Hospital Universitario Rio Hortega

Valladolid, Spain

Location

Servicio Oftalmología (Unidad Córnea Y Superficie Ocular) - Hospital do Meixoeiro Camino De Meixoeiro

Vigo, Spain

Location

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

Levofloxacin; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Francesco Bandello, Prof.

  Ospedale San Raffaele IRCCS S.r.l.

  PRINCIPAL INVESTIGATOR

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

Model Details: Randomized, parallel-group, blinded-assessor study

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 27, 2024
• Study Start: November 5, 2021
• Primary Completion: June 14, 2023
• Study Completion: September 19, 2023
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

ES (5); IT (27); DE (1); RU (8)