Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616922
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Assessment of the Effects and Tolerability of RD032016 for the Treatment of Bacterial Conjunctivitis in Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessment of the Effects and Tolerability of RD032016 Levofloxacin Ketorolac Trometamol 0505 wv Eye Drops Solution for the Treatment of Bacterial Conjunctivitis in Adults a Multicentre Randomized Blinded-assessor Phase II Non Inferiority Study - MIRAKLE
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIRAKLE
Brief Summary:
This is a phase II randomized parallel-group blinded-assessor multicentre study to assess the non-inferiority of RD032016 eye drops vs levofloxacin eye drops alone 11 in microbiological eradication in patients with a clinical diagnosis of bacterial conjunctivitis with moderatesevere signs
Detailed Description:
This study will enroll 252 patients with clinical diagnosis of acute bacterial conjunctivitis with moderatesevere signs score 2 for each cardinal sign ie 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 eyePROnet
Test product ie RD032016 - Levofloxacin Ketorolac Trometamol 0505 wv eye drops solution is the first fixed dose association between a quinolone antibiotic ie levofloxacin highly effective on the pathogenic bacteria that most frequently cause eye infections and a nonsteroidal anti-inflammatory drug NSAID ie ketorolac highly effective in the control of signs and symptoms associated with inflammation
The dosage proposed for RD032016 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 moderatesevere signs and symptoms requiring an anti-inflammatory treatment for rapid symptomatic improvement the use of RD032016 compared to treatment with levofloxacin alone could lead to a substantial simplification of the therapeutic regimen without changing the rate of microbiological eradication
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 eyePROnet
Test product ie RD032016 - Levofloxacin Ketorolac Trometamol 0505 wv eye drops solution is the first fixed dose association between a quinolone antibiotic ie levofloxacin highly effective on the pathogenic bacteria that most frequently cause eye infections and a nonsteroidal anti-inflammatory drug NSAID ie ketorolac highly effective in the control of signs and symptoms associated with inflammation
The dosage proposed for RD032016 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 moderatesevere signs and symptoms requiring an anti-inflammatory treatment for rapid symptomatic improvement the use of RD032016 compared to treatment with levofloxacin alone could lead to a substantial simplification of the therapeutic regimen without changing the rate of microbiological eradication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None