NCT06616922

Assessment of the Effects and Tolerability of RD03/2016 for the Treatment of Bacterial Conjunctivitis in Adults

Assessment of the Effects and Tolerability of RD03/2016 (Levofloxacin; Ketorolac Trometamol 0.5+0.5% w/v Eye Drops Solution) for the Treatment of Bacterial Conjunctivitis in Adults: a Multicentre, Randomized, Blinded-assessor, Phase II Non Inferiority Study - MIRAKLE

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: NTC srl · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will enroll 252 patients with clinical diagnosis of acute bacterial conjunctivitis with moderate/severe signs (score ≥ 2 for each cardinal sign, i.e., bulbar conjunctival injection, palpebral conjunctival injection and conjunctival discharge). Enrolled patients will attend three study visits: baseline (Day 0), On-Therapy (OT; Day 3-4) and final visit (Day 7-9). The duration of the study for each patient will be 7-9 days. Enrolled patients will undergo the following assessments: anamnesis; ophthalmological examination; swab of the lower conjunctiva for bacteriological examination, and a urine pregnancy test (for women of childbearing potential). Patients will be provided with a study smartphone to take photographs of the affected eye at home. Photographs will be taken by the person (a relative or a caregiver) assisting the patient and uploaded on the server of the study eCRF through eyePRO.net. Test product (i.e. RD03/2016 - Levofloxacin; Ketorolac Trometamol 0.5+0.5% w/v eye drops solution) is the first fixed dose association between a quinolone antibiotic (i.e. levofloxacin) highly effective on the pathogenic bacteria that most frequently cause eye infections, and a nonsteroidal anti-inflammatory drug (NSAID) (i.e. ketorolac) highly effective in the control of signs and symptoms associated with inflammation. The dosage proposed for RD03/2016 is one drop 4 times a day for 5 days, lower than that currently approved for levofloxacin alone. In patients with clinical diagnosis of bacterial conjunctivitis and in presence of moderate/severe signs and symptoms requiring an anti-inflammatory treatment for rapid symptomatic improvement, the use of RD03/2016 compared to treatment with levofloxacin alone could lead to a substantial simplification of the therapeutic regimen, without changing the rate of microbiological eradication.

Conditions

• Conjunctivitis, Bacterial

Interventions

Type	Name	Description
DRUG	RD03/2016 eye drops	1 drop, 4 times a day (approximately every 4 hours while awake) for 5 days starting from Day 1.
DRUG	Levofloxacin 0.5% eye drops solution (Oftaquix®)	1 drop, 8 times a day (approximately every 2 hours while awake) on Days 1 and 2, and 1 drop, 4 times a day (approximately every 4 hours while awake) on Days 3 through 5.

Timeline

• Start date: 2021-11-05
• Primary completion: 2023-06-14
• Completion: 2023-09-19
• First posted: 2024-09-27
• Last updated: 2024-09-27

Locations

41 sites across 4 countries: Germany, Italy, Russia, Spain