Fusidic Acid 1%
DrugFusidic acid 1%
NCT Number: NCT06911424
The purpose of this clinical trial is to demonstrate the superiority of fusidic acid 1% over placebo in adults and children with confirmed bacterial conjunctivitis and to further establish the safety profile of fusidic acid 1% for topical ocular administration.
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Interventional
Phase 3
Baxis Site 04, Little Rock, Arkansas, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Main Inclusion Criteria:
Main Exclusion Criteria:
Fusidic acid 1%
Placebo ophthalmic solution
Time frame: Visit 2 (Day 4)
Proportion of patients with a positive bacterial culture at Visit 1 (Day 1) who achieve clinical cure.
Time frame: Visit 2 (Day 4)
Proportion of subjects with a positive bacterial culture at Visit 1 (Day 1) who achieve microbiological eradication.
Time frame: Visit 3 (Day 8)
Proportion of subjects with a positive bacterial culture at Visit 1 (Day 1) who achieve microbiological eradication.
Time frame: Visit 3 (Day 8)
Proportion of patients with a positive bacterial culture at Visit 1 (Day 1) who achieve clinical cure.
Contact information is provided by the study sponsor or research team.
Baxis Pharmaceuticals, Inc.
Industry
A Phase 3 Randomized, Multi-Center, Placebo-Controlled, Masked Study to Evaluate the Clinical Efficacy and Safety of Fusidic Acid 1% Viscous Topical Antibiotic Eye Drops for the Treatment of Suspected Bacterial Conjunctivitis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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