Bacterial conjunctivitis MedDRA version: 20.0 Level: PT Classification code 10061784 Term: Conjunctivitis bacterial System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: RD03/2016
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: LEVOFLOXACIN
CAS Number: 100986-85-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
C
Sponsors
NTC SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ability of patient to consent and provide signed written informed consent 2. Male or female aged major/= 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 (see Study procedures) 6. Willing to interrupt the use of contact lenses for the entire duration of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 126 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 126
Exclusion criteria
Exclusion criteria: 1. Any acute ocular 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority of RD03/2016 eye drops vs. levofloxacin alone in microbiological eradication at final visit (Day 7-9);Secondary Objective: -To assess the efficacy of RD03/2016 eye drops vs. levofloxacin alone in the proportion of patients with clinical cure, i.e. resolution of cardinal signs of bacterial conjunctivitis, at On-Therapy (OT) visit (Day 3-4) and final visit (Day 7- 9). -To assess the efficacy of RD03/2016 eye drops vs. levofloxacin alone in time to clinical cure, assessed through photographs taken every 12 ± 1 hours from Day 1 to Day 7-9, using eyePRO.net (photographs on Day 0 to be taken at the earliest feasible time point post-baseline visit) - To assess the efficacy of RD03/2016 eye drops vs. levofloxacin alone in time to resolution of symptoms of bacterial conjunctivitis. - To evaluate the safety and tolerability of RD03/2016 eye drops - To evaluate compliance with the prescribed treatment For other secondary objectives see the protocol.;Primary end point(s): - Proportion of patients with microbiological eradication i.e. absence/no growth of baseline pathogens assessed through bacteriological culture (calcium alginate swab of the lower conjunctiva) at final visit (Day 7-9);;Timepoint(s) of evaluation of this end point: Days 7-9 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Proportion of patients with clinical cure, i.e. absence of cardinal signs of bacterial conjunctivitis (conjunctival discharge, bulbar conjunctival injectionand palpebral conjunctival injection) at OT visit (Day 3-4) and final visit (Day 7-9); -Time to clinical cure assessed through photographs taken every 12 ± 1 hours from Day 1 to Day 7-9, using the study smartphone and eyePRO.net; - Time to resolution (absence) of bacterial conjunctivitis symptoms (pain, burning/stinging, itching, tearing, foreign body sensation, photophobia and discomfort) recorded by the patient (0, absent; 1, present) every 12 ± 1 hours from Day 1 to Day 7-9 through an electronic patient diary;;Timepoint(s) of evaluation of this end point: Days 7-9 | — |
Countries
Germany, Italy, Portugal, Russian Federation, Spain
Contacts
Public ContactMedical Department
OPIS s.r.l.
Outcome results
None listed