Assessment of the Effects and Tolerability of RD03/2016 for the Treatment of Bacterial Conjunctivitis in Adults
- Conditions
- Conjunctivitis, Bacterial
- Interventions
- Drug: RD03/2016 eye drops
- Registration Number
- NCT06616922
- Lead Sponsor
- NTC srl
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 252
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test arm RD03/2016 eye drops Patients will be randomly assigned (1:1) to one of the two treatment groups Standard drug arm Levofloxacin 0.5% eye drops solution (Oftaquix®) Patients will be randomly assigned (1:1) to one of the two treatment groups
- Primary Outcome Measures
Name Time Method Proportion of patients with microbiological eradication At the Final visit (Day 7-9) 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).
- Secondary Outcome Measures
Name Time Method By-pathogen microbiological eradication rate of levofloxacin-susceptible bacteria At baseline that are eradicated at the final visit (Day 7-9) Proportion of levofloxacin-susceptible pathogenic 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) Proportion of patients (pooling both treatment groups) with microbiological eradication (i.e., absence/no growth of pathogenic microorganisms or reduction below pathogenic criteria of opportunistic microorganisms) of bacteria intermediate or resistant to levofloxacin at baseline (as assessed through bacteriological culture and antibiotic susceptibility testing), 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 pathogenic bacteria intermediate or resistant to levofloxacin at baseline (pooling both treatment groups) 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) Absence or at least one-unit improvement vs. baseline of all cardinal signs of bacterial conjunctivitis (conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection) at OT visit (Day 3-4) and final visit (Day 7-9).
Time to clinical cure Every 12 ± 1 hours from Day 0 to Day 7-9 Absence or at least one-unit improvement vs. baseline of all cardinal signs of bacterial conjunctivitis (conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection), assessed through photographs taken every 12 ± 1 hours from Day 0 to Day 7-9, using the study smartphone and eyePRO.net.
Time to resolution (absence) of bacterial conjunctivitis symptoms Every 12 ± 1 hours from Day 0 to Day 7-9 Time to resolution (absence) of bacterial conjunctivitis symptoms (i.e. pain, burning/stinging, itching, tearing, foreign body sensation, photophobia and discomfort) recorded by the patient every 12 ± 1 hours from Day 0 to Day 7-9 through the electronic patient diary.
Trial Locations
- Locations (41)
Centro Polispecialistico Achille Sicari
🇮🇹Carrara, Italy
ASST Franciacorta - Ospedale di Chiari
🇮🇹Chiari, Italy
Städtisches Klinikum Karlsruhe Augenklinik
🇩🇪Karlsruhe, Germany
Clinica Oftalmologica Ospedale SS Annunziata
🇮🇹Chieti, Italy
A.O.U. Policlinico Consorziale di Bari
🇮🇹Bari, Italy
ASST Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Ospedale della Versilia
🇮🇹Camaiore, Italy
Presidio Ospedaliero G. Rodolico - A.O.U. "Policlinico - Vittorio Emanuele"
🇮🇹Catania, Italy
Clinica Oculistica Azienda Ospedaliero-Universitaria Careggi di Firenze
🇮🇹Firenze, Italy
Clinica Oculistica Azienda Ospedaliero - Universitaria Policlinico "G. Martino"
🇮🇹Messina, Italy
ASST Fatebenefratelli Sacco - Istituto Fatebenefratelli e Oftalmico
🇮🇹Milano, Italy
ASST Fatebenefratelli Sacco
🇮🇹Milano, Italy
ASST Santi Carlo e Paolo
🇮🇹Milano, Italy
Clinica Oculistica Ospedale San Giuseppe
🇮🇹Milano, Italy
Ospedale Maggiore Policlinico - U.O. Oculistica Fondazione IRCCS Ca' Granda
🇮🇹Milano, 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
Federal State Autonomous Institution "S.N. Fedorov National Medical Research Center "MNTK "Eye Microsurgery" of the Ministry of Health of the Russian Federation
🇷🇺Moscow, Russian Federation
Federal State Budgetary Educational Institution of High Professional Education "Moscow State Medical Stomatology University named after A.I.Evdokimov"
🇷🇺Moscow, Russian Federation
Azienda Ospedaliera Universitaria Senese
🇮🇹Siena, Italy
Ospedale di Treviso, AULSS2 Treviso
🇮🇹Treviso, Italy
State Budgetary Institution "National Medical Research Center for Eye Diseases named after Helmholts" of the Ministry of Healthcare of the Russian Federation
🇷🇺Moscow, Russian Federation
Azienda Ospedaliera Universitaria Integrata Verona
🇮🇹Verona, Italy
Regional Budgetary Institution of Healthcare "Ivanovo Regional Clinical Hospital"
🇷🇺Ivanovo, Russian Federation
Servicio Oftalmología (Unidad Córnea Y Superficie Ocular) - Hospital do Meixoeiro Camino De Meixoeiro
🇪🇸Vigo, Spain
State Budgetary Healthcare Institution of the Omsk Region "Clinical Ophthalmological Hospital named after V.P. Vykhodtsev"
🇷🇺Omsk, Russian Federation
Private Institution of Healthcare "Clinical hospital "RR-Medicine" of the city of Saint-Petersburg"
🇷🇺Saint Petersburg, Russian Federation
LLC Sphera-Med
🇷🇺San Pietroburgo, Russian Federation
State Budgetary Healthcare Institution of Yaroslavl Region "Clinical Hospital #2"
🇷🇺Yaroslavl, Russian Federation
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