Assessment of the effects and tolerability of RD03/2016 eye drops for the treatment of bacterial conjunctivitis in adults

Phase 1

• Conditions: Bacterial conjunctivitis; MedDRA version: 20.0Level: PTClassification code 10061784Term: Conjunctivitis bacterialSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2020-005263-31-DE
• Lead Sponsor: TC s.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-18
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 252

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified