Assessment of the Effects and Tolerability of RD03/2016 for the Treatment of Bacterial Conjunctiv… (NCT06616922) | Clinical Trial Compass
CompletedPhase 2
Assessment of the Effects and Tolerability of RD03/2016 for the Treatment of Bacterial Conjunctivitis in Adults
Germany, Italy252 participantsStarted 2021-11-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
Exclusion criteria
✕. 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).
What they're measuring
1
Proportion of patients with microbiological eradication
✕. 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.