A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a study to investigate a novel drug candidate for the treatment of bacterial conjunctivitis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis

NCT00972777

Bacterial Conjunctivitis

COMPLETED PHASE2/PHASE3

Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis

NCT01740388

Bacterial Conjunctivitis

TERMINATED PHASE3

Moxifloxacin vs. Polytrim for Conjunctivitis

NCT00581542

Conjunctivitis

COMPLETED PHASE4

Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Bacterial Conjunctivitis

NCT05816070

Acute Bacterial Conjunctivitis

COMPLETED PHASE2

An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% ((VIGAMOX®) Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients

NCT01573910

Bacterial Conjunctivitis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Bacterial Conjunctivitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Moxifloxacin solution

Moxifloxacin hydrochloride ophthalmic solution 0.5%

Group Type ACTIVE_COMPARATOR

Moxifloxacin solution

Intervention Type DRUG

Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days.

Besifloxacin Suspension

Besifloxacin hydrochloride ophthalmic suspension 0.6%

Group Type EXPERIMENTAL

Besifloxacin

Intervention Type DRUG

Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Besifloxacin

Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days

Intervention Type DRUG

Moxifloxacin solution

Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.

Exclusion Criteria

* Pregnant or nursing females.
* Use of any antibiotic within 72 hours of enrollment.
* Any disease conditions that could interfere with the safety and efficacy evaluations of the study drug.
* Participation in an ophthalmic drug or device research study within 30 days prior to entry into this study.

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No