Assessment of the Effects and Tolerability of RD03/2016 for the Treatment of Bacterial Conjunctivitis in Adults
- 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.
- Acronym
- MIRAKLE
- Short title
- Assessment of the Effects and Tolerability of RD03/2016 for the Treatment of Bacterial Conjunctivitis in Adults
- Official title
- Assessment of the Effects and Tolerability of RD03/2016 (Levofloxacin; Ketorolac Trometamol 0.5+0.5% w/v Eye Drops Solution) for the Treatment of Bacterial Conjunctivitis in Adults: a Multicentre, Randomized, Blinded-assessor, Phase II Non Inferiority Study - MIRAKLE
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2023-09-19
- First posted
- 2024-09-27
- Registry last updated
- 2024-09-27
- Primary completion date
- 2023-06-14
- Start date
- 2021-11-05
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- NTC srl
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06616922
- ClinicalTrials.gov ID
- NCT06616922
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Single masking
- Masked roles
- Investigators
Proportion of patients with microbiological eradication
Timeframe: 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).
By-pathogen microbiological eradication rate of levofloxacin-susceptible bacteria
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
- Städtisches Klinikum Karlsruhe AugenklinikKarlsruhe, Germany
- A.O.U. Policlinico Consorziale di BariBari, Italy
- ASST Papa Giovanni XXIIIBergamo, Italy
- Ospedale della VersiliaCamaiore, Italy
- Centro Polispecialistico Achille SicariCarrara, Italy
- Presidio Ospedaliero G. Rodolico - A.O.U. "Policlinico - Vittorio Emanuele"Catania, Italy
- ASST Franciacorta - Ospedale di ChiariChiari, Italy
- Clinica Oftalmologica Ospedale SS AnnunziataChieti, Italy
- Clinica Oculistica Azienda Ospedaliero-Universitaria Careggi di FirenzeFlorence, Italy
- Clinica Oculistica Azienda Ospedaliero - Universitaria Policlinico "G. Martino"Messina, Italy
- ASST Fatebenefratelli Sacco - Istituto Fatebenefratelli e OftalmicoMilan, Italy
- ASST Fatebenefratelli SaccoMilan, Italy
- ASST Santi Carlo e PaoloMilan, Italy
- Clinica Oculistica Ospedale San GiuseppeMilan, Italy
- Ospedale Maggiore Policlinico - U.O. Oculistica Fondazione IRCCS Ca' GrandaMilan, Italy
- Oculistica Ospedale G. FoglianiMilazzo, Italy
- U.O.S.C. Oculistica Az. Osp. di Rilievo Nazionale A. CardarelliNaples, Italy
- A.O.U. Policlinico P. GiacconePalermo, Italy
- ARNAS Civico Di Cristina BenfratelliPalermo, Italy
- Presidio Ospedaliero di Cisanello - Azienda Ospedaliero Universitaria PisanaPisa, Italy
- Azienda Ospedaliera Sant'AndreaRoma, Italy
- Fondazione Policlinico Universitario - IRCSS Agostino GemelliRoma, Italy
- IRCCS Fondazione G.B. BiettiRoma, Italy
- IRCCS Casa Sollievo della SofferenzaSan Giovanni Rotondo, Italy
- S.S. Annunziata di SaviglianoSavigliano, Italy
And 16 more, listed on the interactive page.
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Bacterial conjunctivitis Primary condition