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Conjunctivitis, BacterialPhase 2MIRAKLENCT06616922

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

A Phase 2 study testing RD03/2016 eye drops and Levofloxacin 0.5% eye drops solution (Oftaquix®) in people with Conjunctivitis, Bacterial, run by NTC srl at 41 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Conjunctivitis, Bacterial
What is being tested?
RD03/2016 eye drops and Levofloxacin 0.5% eye drops solution (Oftaquix®)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
41 sitesin 4 countries
Study dates
5 Nov 2021to 19 Sep 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

41 sites in 4 countries.

41 sites in 4 countries

Italy27 sites

  • A.O.U. Policlinico Consorziale di Bari

    Bari

  • ASST Papa Giovanni XXIII

    Bergamo

  • Ospedale della Versilia

    Camaiore

  • Centro Polispecialistico Achille Sicari

    Carrara

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

    Catania

  • ASST Franciacorta - Ospedale di Chiari

    Chiari

  • Clinica Oftalmologica Ospedale SS Annunziata

    Chieti

  • Clinica Oculistica Azienda Ospedaliero-Universitaria Careggi di Firenze

    Florence

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

    Messina

  • ASST Fatebenefratelli Sacco - Istituto Fatebenefratelli e Oftalmico

    Milan

  • ASST Fatebenefratelli Sacco

    Milan

  • ASST Santi Carlo e Paolo

    Milan

  • Clinica Oculistica Ospedale San Giuseppe

    Milan

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

    Milan

  • Oculistica Ospedale G. Fogliani

    Milazzo

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

    Naples

  • A.O.U. Policlinico P. Giaccone

    Palermo

  • ARNAS Civico Di Cristina Benfratelli

    Palermo

  • Presidio Ospedaliero di Cisanello - Azienda Ospedaliero Universitaria Pisana

    Pisa

  • Azienda Ospedaliera Sant'Andrea

    Roma

  • Fondazione Policlinico Universitario - IRCSS Agostino Gemelli

    Roma

  • IRCCS Fondazione G.B. Bietti

    Roma

  • IRCCS Casa Sollievo della Sofferenza

    San Giovanni Rotondo

  • S.S. Annunziata di Savigliano

    Savigliano

  • Azienda Ospedaliera Universitaria Senese

    Siena

  • Ospedale di Treviso, AULSS2 Treviso

    Treviso

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona

Other trials in Italy

Russia8 sites

  • Regional Budgetary Institution of Healthcare "Ivanovo Regional Clinical Hospital"

    Ivanovo

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

    Moscow

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

    Moscow

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

    Moscow

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

    Omsk

  • LLC Sphera-Med

    Saint Petersburg

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

    Saint Petersburg

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

    Yaroslavl

Other trials in Russia

Spain5 sites

  • Sección De Cornea, Hospital Universitario La Paz

    Madrid

  • Ophthalmology Unit Empresa Pública Hospital Costa del Sol

    Marbella

  • Hospital La Fe Avenida de Fernando Abril Martorell

    Valencia

  • Servicio De Oftalmología Hospital Universitario Rio Hortega

    Valladolid

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

    Vigo

Other trials in Spain

Germany1 site

  • Städtisches Klinikum Karlsruhe Augenklinik

    Karlsruhe

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
RD03/2016 eye drops, Levofloxacin 0.5% eye drops solution (Oftaquix®)
Keywords
RD03/2016, Levofloxacin
Medical subject headings
Conjunctivitis, Bacterial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RD03/2016 eye dropsDrug

    Also called Levofloxacin + Ketorolac Trometamol 0.5+0.5% w/v eye drops solution

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

  • Levofloxacin 0.5% eye drops solution (Oftaquix®)Drug

    Also called Oftaquix® 5 mg/ml eye drops solution

    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.

Study groups in NCT06616922
Study groupRoleWhat they receive
Test armExperimentalPatients will be randomly assigned (1:1) to one of the two treatment groups
Receives: Drug: RD03/2016 eye drops
Standard drug armActive comparatorPatients will be randomly assigned (1:1) to one of the two treatment groups
Receives: Drug: Levofloxacin 0.5% eye drops solution (Oftaquix®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: At the Final visit (Day 7-9)

Secondary outcomes (6)

  1. By-pathogen microbiological eradication rate of levofloxacin-susceptible bacteria

    Proportion of levofloxacin-susceptible pathogenic bacteria at baseline that are eradicated at the final visit (Day 7-9).

    Measured: 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

    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).

    Measured: At the final visit (Day 7-9)

  3. Overall by-pathogen microbiological eradication rate of bacteria intermediate or resistant to levofloxacin

    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).

    Measured: At baseline that are eradicated at the final visit (Day 7-9)

  4. Proportion of patients with clinical cure

    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).

    Measured: At Day 3-4 and final visit (Day 7-9)

  5. Time to clinical cure

    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.

    Measured: Every 12 ± 1 hours from Day 0 to Day 7-9

  6. Time to resolution (absence) of bacterial conjunctivitis symptoms

    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.

    Measured: Every 12 ± 1 hours from Day 0 to Day 7-9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2024
  2. Study start5 Nov 2021
  3. Primary completion14 Jun 2023
  4. Study completion19 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, parallel-group, blinded-assessor study
Masking
Single blind
Who is masked
Investigator
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06616922
Sponsor's protocol ID
LEVOKETO_02-2020
Acronym
MIRAKLE
Status last verified
Sep 2024
First submitted
20 Sep 2024
Last updated
27 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RD03/2016 eye drops and Levofloxacin 0.5% eye drops solution (Oftaquix®) in people with Conjunctivitis, Bacterial, run by NTC srl at 41 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Italy, Russia, Spain, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with microbiological eradication (time frame: At the Final visit (Day 7-9)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06616922.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.

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