Infections of the outer eye layers (mainly bacterial conjuctivitis ) MedDRA version: 16.0 Level: PT Classification code 10010742 Term: Conjunctivitis infective System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: THILOCOF 1% Eye Drops Solution
Product Name: Azidamfenicol
Product Code: 1773301
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: AZIDAMFENICOL
CAS Number: 13838-08-9
Other de
Sponsors
FARMEX SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women, of = or > 18 years of age 2. Subjects with a clinical diagnosis of outer eye layer(s) infection (i.e. subjects with a diagnosis of bacterial conjuctivitis, cornea-conjuctivitis, blepharitis or blepharo-conjuctivitis) 3. Subjects who present conjuctival hyperemia and at least one of the following signs: • purulent of mucopurulent exudate, • formation of scabs on eyelashes • redness & thickness of the free eyelash rim • eyelashes loss (of various degree) 4. Subjects willing to and capable of attending the study visits within the visits' allowed time windows. 5. Subjects who have signed the Informed Consent. 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Patients aged <18 years 2. Patients who present with symptoms for more than 7 days 3. Patients with typical signs and/or symptoms of chlamydia, viral or fungal infection 4. Patients with an inflammation of allergic aetiology . 5. Patients with severe systemic infections 6. Patients receiving systemic antimicrobial treatment 7. Patients who underwent treatment with topical, ophthalmic antimicrobial or steroid medications during the last two weeks before their enrollment in the study. 8. Patients who underwent an ophthalmic surgery during the last 3 months before their enrollment in the study 9. Patients suffering from other ophthalmic diseases that may interfere with the outcomes of this study. 10. Patients with a history of severe allergy or known hypersensitivity to the study drugs or known hypersensitivity to any of the study drugs components, especially patients with a history of blood dyscrasias or patients who presented with bone marrow suppression following the administration of azidamfenicol eye drops solution 11. Pregnant of breast-feeding women. 12. Women of child-bearing potential who do not use adequate contraceptive measures. 13. Patients who, according the the investigator's opinion, are unlikely to comply with the study protocol or who are incapable to participate for any other reason or who do not wish to sign the Informed Consent form .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The comparative assessment of the efficacy of azidamfenicol eye drops (Thilocof®/FARMEX) vs. tobramycin eye drops (?obrex®/Alcon) in the treatement of patients with infections of the outer eye layers (bacterial conjuctivitis );Secondary Objective: •to evaluate the safety of azidamfenicol eye drops (Thilocof®/FARMEX) vs. tobramycin eye drops (?obrex®/Alcon) in the treatement of patients with infections of the outer eye layers (bacterial conjuctivitis ) •to explore for any differences in the time of occurence of signs and symptoms improvement between the azidamfenicol eye drops (Thilocof®/FARMEX) vs. tobramycin eye drops (?obrex®/Alcon) in the treatement of patients with infections of the outer eye layers (bacterial conjuctivitis ) •to explore for any differences in the quality of life between the azidamfenicol eye drops (Thilocof®/FARMEX) vs. tobramycin eye drops (?obrex®/Alcon) in the treatement of patients with infections of the outer eye layers (bacterial conjuctivitis ) ;Primary end point(s): Co-primary endpoints are: - the assessment of the ophthalmic smear's culture (day 1 & 7), and - the assessment of the bacterial conjuctivitis signes & symptoms grading system score (days 1, 3 & 7) ;Timepoint(s) of evaluation of this end point: Day 1, Day 3, Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The change in the score of the IGII scale (Investigator Global Improvement Index) and the change of the score of the PGII scale (Patient Global Improvement Index) (Day 7).;Timepoint(s) of evaluation of this end point: Day 7 | — |
Countries
Greece
Contacts
Public ContactNikolaos Papazoglou
FARMEX SA
Outcome results
None listed