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

NCT06616922 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2024-09-27

No results posted yet for this study

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.

Conditions

  • Conjunctivitis, Bacterial

Interventions

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.

Sponsors & Collaborators

  • NTC srl

    lead INDUSTRY

Principal Investigators

  • Francesco Bandello, Prof. · Ospedale San Raffaele IRCCS S.r.l.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-05
Primary Completion
2023-06-14
Completion
2023-09-19

Countries

  • Germany
  • Italy
  • Russia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06616922 on ClinicalTrials.gov