A Phase 2 interventional study of RD03/2016 eye drops and Levofloxacin 0.5% eye drops solution (Oftaquix®) in Conjunctivitis, Bacterial, sponsored by NTC srl. Completed at 41 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by NTC srl · Phase 2, Interventional, and Treatment
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.
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.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 252 is close to the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.
Browse Conjunctivitis, Bacterial studies →NTC srl is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be randomly assigned (1:1) to one of the two treatment groups
Drug: RD03/2016 eye drops
Patients will be randomly assigned (1:1) to one of the two treatment groups
Drug: Levofloxacin 0.5% eye drops solution (Oftaquix®)
1 drop, 4 times a day (approximately every 4 hours while awake) for 5 days starting from Day 1.
Also known as: Levofloxacin + Ketorolac Trometamol 0.5+0.5% w/v 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.
Also known as: Oftaquix® 5 mg/ml eye drops solution
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).
Time frame: At the Final visit (Day 7-9)
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).
Time frame: 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
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).
Time frame: At the final visit (Day 7-9)
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).
Time frame: At baseline that are eradicated at the final visit (Day 7-9)
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).
Time frame: At Day 3-4 and final visit (Day 7-9)
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.
Time frame: Every 12 ± 1 hours from Day 0 to Day 7-9
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.
Time frame: Every 12 ± 1 hours from Day 0 to Day 7-9
Safety: Adverse events throughout the study
The number of patients with adverse events, and the number and types of events will be recorded throughout the study
Time frame: Throughout the study, from Day 0 to Day 7-9
Local tolerability: Ocular itching/burning or discomfort related to study drug instillation
Ocular itching/burning or discomfort related to study drug instillation, assessed by a Numeric Rating Scale (NRS) (0 = no itching/burning or discomfort to 10 = unbearable itching/burning or discomfort), through the electronic patient diary.
Time frame: Twice a day, from Day 0 to Day 5
Compliance: Assessment of the number of instillations
Number of study drug instillations, assessed through the electronic patient diary from Day 1 to Day 5
Time frame: From Day 1 to Day 5
Feasibility: Microbiological eligibility rate
The proportion of screened patients with positive culture for levofloxacin-sensitive bacteria.
Time frame: At the Final visit (Day 7-9)
Feasibility: Patient confidence in using the study smartphone and eyePRO.net
Taking photographs of the study eye, as well as in following the picture-capturing procedure as per Investigator's instructions. The confidence of the patient in using the study smartphone and eyePRO.net is assessed through a questionnaire on the final visit (Day 7-9) by means of NRSs of 'Ease of using the smartphone', 'Ease of use of eyePRO.net', and 'Ease of following the picture-capturing procedures' (range 0-10, where 0 indicates 'very difficult' and 10 indicates 'very easy').
Time frame: At the Final visit (Day 7-9)
Feasibility part 1: Assessment of the mean number of pictures uploaded at a time through eyePRO.net
Mean timing of picture upload for each patient deemed suitable for clinical evaluation by the central team of blinded assessors.
Time frame: At the Final visit (Day 7-9)
Feasibility part 2: Assessment of the mean number of pictures uploaded at a time through
Mean the percentage of timely picture uploads for each patient deemed suitable for clinical evaluation by the central team of blinded assessors.
Time frame: At the Final visit (Day 7-9)
Feasibility part 3: Assessment of the mean number of pictures uploaded at a time through
Mean the percentage of uploaded pictures for each patient deemed suitable for clinical evaluation by the central team of blinded assessors.
Time frame: At the Final visit (Day 7-9)
Feasibility: Accuracy of photographic assessments of clinical cure against the gold standard direct ocular examination
Sensitivity, specificity, positive predictive value and negative predictive value of photographic assessments of clinical cure against the gold standard direct ocular examination at both the on-therapy and final visits
Time frame: At the Final visit (Day 7-9)
Ran from Nov 2021 to primary completion in Jun 2023, 19 months.
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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