> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/assessment-of-the-effects-and-tolerability-of-rd03-2016-for-46fbf863-68fb-4cae-9486-cc9e7cdde889 > Record changed: 2026-11-04 # Assessment of the Effects and Tolerability of RD03/2016 for the Treatment of Bacterial Conjunctivitis in Adults NCT06616922 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) Participants 252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) Lead sponsor NTC srl Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) Start date 2021-11-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) Number of sites 41 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **Acronym** MIRAKLE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **Short title** Assessment of the Effects and Tolerability of RD03/2016 for the Treatment of Bacterial Conjunctivitis in Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) ## Dates **Completion date** 2023-09-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **First posted** 2024-09-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **Registry last updated** 2024-09-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **Primary completion date** 2023-06-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **Start date** 2021-11-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) ## Size and sites **Actual participants** 252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **Participants** 252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **Number of sites** 41 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **Lead sponsor** NTC srl Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) ## Identifiers **Registry ID** NCT06616922 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **ClinicalTrials.gov ID** NCT06616922 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Single masking **Masked roles** Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) ## Outcomes ### Primary outcomes 1. 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). ### Secondary outcomes 1. 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). 2. 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). 3. 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). 4. 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). 5. 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. 6. 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) ## Sites - 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. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06616922) ## Related records ### Drugs (1) - [Levofloxacin](https://trialight.com/data/asset/levofloxacin-091d90d2-35bb-4b1e-b685-02b522e966f5.md) ### Lead sponsors (1) - [NTC srl](https://trialight.com/data/company/ntc-srl-2003aeae-4565-47e7-bf50-1831b089832a.md) ### Conditions (1) - [Bacterial conjunctivitis](https://trialight.com/data/condition/bacterial-conjunctivitis-f2cf0895-23b7-5092-95f1-5c304329699f.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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