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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with microbiological eradication
. 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.