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

NCT ID: NCT06616922

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-05
• Study Completion Date: 2023-09-19

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.

Detailed Description

This study will enroll 252 patients with clinical diagnosis of acute bacterial conjunctivitis with moderate/severe signs (score ≥ 2 for each cardinal sign, i.e., bulbar conjunctival injection, palpebral conjunctival injection and conjunctival discharge).

Enrolled patients will attend three study visits: baseline (Day 0), On-Therapy (OT; Day 3-4) and final visit (Day 7-9). The duration of the study for each patient will be 7-9 days.

Enrolled patients will undergo the following assessments: anamnesis; ophthalmological examination; swab of the lower conjunctiva for bacteriological examination, and a urine pregnancy test (for women of childbearing potential). Patients will be provided with a study smartphone to take photographs of the affected eye at home. Photographs will be taken by the person (a relative or a caregiver) assisting the patient and uploaded on the server of the study eCRF through eyePRO.net.

Test product (i.e. RD03/2016 - Levofloxacin; Ketorolac Trometamol 0.5+0.5% w/v eye drops solution) is the first fixed dose association between a quinolone antibiotic (i.e. levofloxacin) highly effective on the pathogenic bacteria that most frequently cause eye infections, and a nonsteroidal anti-inflammatory drug (NSAID) (i.e. ketorolac) highly effective in the control of signs and symptoms associated with inflammation.

The dosage proposed for RD03/2016 is one drop 4 times a day for 5 days, lower than that currently approved for levofloxacin alone. In patients with clinical diagnosis of bacterial conjunctivitis and in presence of moderate/severe signs and symptoms requiring an anti-inflammatory treatment for rapid symptomatic improvement, the use of RD03/2016 compared to treatment with levofloxacin alone could lead to a substantial simplification of the therapeutic regimen, without changing the rate of microbiological eradication.

Conditions

Conjunctivitis, Bacterial

Keywords

RD03/2016; Levofloxacin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test arm

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

Group Type: EXPERIMENTAL

RD03/2016 eye drops

Intervention Type: DRUG

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

Standard drug arm

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

Group Type: ACTIVE_COMPARATOR

Levofloxacin 0.5% eye drops solution (Oftaquix®)

Intervention Type: 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.

Interventions

RD03/2016 eye drops

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

Intervention Type: DRUG

Levofloxacin 0.5% eye drops solution (Oftaquix®)

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.

Intervention Type: DRUG

Other Intervention Names

Levofloxacin + Ketorolac Trometamol 0.5+0.5% w/v eye drops solution; Oftaquix® 5 mg/ml eye drops solution

Eligibility Criteria

Inclusion Criteria

1. Ability of patient to consent and provide signed written informed consent

2. Male or female aged ≥ 18 year.

3. 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).

4. Able and willing to follow study procedures.

5. 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.

6. Willing to interrupt the use of contact lenses for the entire duration of the study.

Exclusion Criteria

1. Any acute ocular clinical disease other than bacterial conjunctivitis.

2. Any ocular surgery (including laser treatment) in the study eye within 30 days prior to study entry.

3. Any ocular (in the study eye) or systemic antimicrobial agents administered concurrently or within 3 days prior to study entry.

4. Any ocular (in the study eye) or systemic steroids or NSAIDs administered concurrently.

5. 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).

6. Participation in previous clinical studies if less than 5 half-lives of the Investigational Medicinal Product (IMP) used have passed.

7. Hypersensitivity to the products, other quinolones, acetylsalicylic acid and other NSAIDs (due to potential for cross-sensitivity), or their excipients.

8. Contraindications to ocular treatment with levofloxacin and/or ketorolac.

9. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NTC srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesco Bandello, Prof.

Role: PRINCIPAL_INVESTIGATOR

Ospedale San Raffaele IRCCS S.r.l.

Locations

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

Clinica Oftalmologica Ospedale SS Annunziata

Chieti, , Italy

Clinica Oculistica Azienda Ospedaliero-Universitaria Careggi di Firenze

Florence, , Italy

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

Messina, , Italy

ASST Fatebenefratelli Sacco - Istituto Fatebenefratelli e Oftalmico

Milan, , Italy

ASST Fatebenefratelli Sacco

Milan, , Italy

ASST Santi Carlo e Paolo

Milan, , Italy

Clinica Oculistica Ospedale San Giuseppe

Milan, , Italy

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

Milan, , Italy

Oculistica Ospedale G. Fogliani

Milazzo, , Italy

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

Napoli, , Italy

A.O.U. Policlinico P. Giaccone

Palermo, , Italy

ARNAS Civico Di Cristina Benfratelli

Palermo, , Italy

Presidio Ospedaliero di Cisanello - Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Azienda Ospedaliera Sant'Andrea

Roma, , Italy

Fondazione Policlinico Universitario - IRCSS Agostino Gemelli

Roma, , Italy

IRCCS Fondazione G.B. Bietti

Roma, , Italy

IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

S.S. Annunziata di Savigliano

Savigliano, , Italy

Azienda Ospedaliera Universitaria Senese

Siena, , Italy

Ospedale di Treviso, AULSS2 Treviso

Treviso, , Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, , Italy

Regional Budgetary Institution of Healthcare "Ivanovo Regional Clinical Hospital"

Ivanovo, , Russia

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

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

Moscow, , Russia

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

Moscow, , Russia

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

Omsk, , Russia

LLC Sphera-Med

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

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

Yaroslavl, , Russia

Sección De Cornea, Hospital Universitario La Paz

Madrid, , Spain

Ophthalmology Unit Empresa Pública Hospital Costa del Sol

Marbella, , Spain

Hospital La Fe Avenida de Fernando Abril Martorell

Valencia, , Spain

Servicio De Oftalmología Hospital Universitario Rio Hortega

Valladolid, , Spain

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

Vigo, , Spain

Countries

Germany; Italy; Russia; Spain

Other Identifiers

LEVOKETO_02-2020

Identifier Type: -

Identifier Source: org_study_id