RECRUITING

Efficacy of Fusidic Acid 1% in the Treatment of Bacterial Conjunctivitis

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Conditions

Bacterial ConjunctivitisConjunctival DiseasesEye DiseasesEye Infections, BacterialBacterial InfectionsInfectionsEye InfectionsConjunctivitis, BacterialConjunctivitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-21
Study Completion:2025-12-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06911424

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye, confirmed by the presence of purulent or mucopurulent ocular discharge and a grade ≥ 1 on the modified Validated Bulbar Redness (VBR) conjunctival redness scale.
  2. * Have not received any ocular treatment for conjunctivitis, aside from eyelid hygiene, ≤14 days prior to Visit 1.
  3. * Have a negative viral conjunctivitis test in both eyes.
  4. * Agree to discontinue use of eye/eyelid cosmetics during study participation.
  5. * Agree to discontinue use of contact lenses during study participation.
  6. * Be willing and able to provide informed consent and comply with the study requirements.
  7. * Not be currently pregnant or breastfeeding. If sexually active, agree to use approved contraception for the duration of the study.
  1. * Have signs and/or symptoms or a diagnosis of fungal, protozoal, or viral etiology ≤30 days prior to Visit 1.
  2. * Have experienced signs and symptoms of bacterial conjunctivitis for \>48 hours prior to Visit 1.
  3. * Require or are expected to require use of any non-study topical ocular medication or systemic medications prior to Visit 1 as specified in the protocol as ineligible.
  4. * Have any abnormality of the ocular anatomy or ocular disease/disorder specified in the protocol as ineligible.
  5. * Have a known intolerance, sensitivity or allergy to the study medications or any of their components.
  6. * Have participated in another clinical trial ≤30 days or received another experimental drug ≤90 days prior to Visit 1.
  7. * Have a family member or household member enrolled in this study.
  8. * Have a condition which in the investigator's opinion may impact their safety or would negatively affect the conduct or outcome of the study.
  9. * Be an employee of or immediate family member of an employee (directly related to study conduct) at the study site.

Contacts and Locations

Study Contact

Director of Clinical Operations
CONTACT
4349808100
info@baxis.com

Study Locations (Sites)

Baxis Site 04
Little Rock, Arkansas, 72205
United States
Baxis Site 24
Huntington Beach, California, 92647
United States
Baxis Site 19
La Jolla, California, 92037
United States
Baxis Site 20
Sherman Oaks, California, 91423
United States
Baxis Site 22
Doral, Florida, 33172
United States
Baxis Site 11
Lake Worth, Florida, 33460
United States
Baxis Site 13
Miami Beach, Florida, 33140
United States
Baxis Site 01
Miami, Florida, 33155
United States
Baxis Site 03
Miami, Florida, 33176
United States
Baxis Site 10
Tampa, Florida, 33613
United States
Baxis Site 15
Idaho Falls, Idaho, 83404
United States
Baxis Site 06
Orland Park, Illinois, 60462
United States
Baxis Site 26
Columbia, Maryland, 21045
United States
Baxis Site 21
North Las Vegas, Nevada, 89030
United States
Baxis Site 23
Babylon, New York, 11702
United States
Baxis Site 05
Mount Airy, North Carolina, 27030
United States
Baxis Site 25
Tulsa, Oklahoma, 74133
United States
Baxis Site 09
Pittsburgh, Pennsylvania, 15227
United States
Baxis Site 12
Charleston, South Carolina, 29414
United States
Baxis Site 08
Edinburg, Texas, 78539
United States
Baxis Site 02
Humble, Texas, 77338
United States
Baxis Site 14
Kingwood, Texas, 77345
United States
Baxis Site 17
Layton, Utah, 84041
United States
Baxis Site 18
Layton, Utah, 84041
United States
Baxis Site 16
West Valley, Utah, 84120
United States

Collaborators and Investigators

Sponsor: Baxis Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-21
Study Completion Date2025-12-22

Study Record Updates

Study Start Date2025-03-21
Study Completion Date2025-12-22

Terms related to this study

Keywords Provided by Researchers

  • Conjunctival Diseases
  • Eye Diseases
  • Eye Infections, Bacterial
  • Bacterial Infections
  • Infections
  • Eye Infections
  • Conjunctivitis, Bacterial
  • Conjunctivitis

Additional Relevant MeSH Terms

  • Bacterial Conjunctivitis