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BOL-303224-A

Phase 1

Conjunctivitis, Bacterial | Small molecule | Ophthalmology |Bausch + Lomb Corporation|Last Updated: Dec 9, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

BOL-303224-A · 1 trial · 1 indication

Phase 1 1
NCT00407589Systemic Pharmacokinetics of BOL-303224-AConjunctivitis, Bacterial
COMPLETED24 Analytics
PHASE1COMPLETED
Systemic Pharmacokinetics of BOL-303224-A
Conjunctivitis, BacterialUnlock trial analytics

Study Endpoints

Primary Endpoints

Assessment of systemic pharmacokinetics following a single dose and steady-state pharmacokinetics after multiple TID dosing
Blood samples will be collected from 0 to 6 hours on Day 1 and from 0 to 12 hours on Day 6. There will be additional sampling times at 0 hours on Day 2-5.

Secondary Endpoints

Investigator ratings of ocular discharge and bulbar conjunctival injection, Visual Acuity, ophthalmoscopy findings and Adverse event collection
Througout the study
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BOL-303224-AEXPERIMENTALSystemic exposure of BOL-303224-A following single and multiple topical doses

Interventions

NameTypeDescription
BOL-303224-ADRUG1 drop in each eye, TID for 5 days at approximately 6 h intervals, with a final, single dose on the morning of Visit 7 (Day 6).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * must be at least 18 years of age, any race * must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in both eyes * women of childbearing potential must utilize reliable contraceptive methods and have a negative ...

Countries:United States
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Frequently asked questions about BOL-303224-A

What is BOL-303224-A used for?

BOL-303224-A is an investigational small molecule being developed for bacterial conjunctivitis, an eye infection. It is in Phase 1 clinical development and is not yet approved by the FDA. The drug is being studied for its systemic pharmacokinetics in patients with this condition.

Who makes BOL-303224-A?

BOL-303224-A is being developed by Bausch + Lomb Corporation, a company traded on the New York Stock Exchange under the ticker BLCO. The company is conducting clinical research on this investigational drug for bacterial conjunctivitis.

What phase is BOL-303224-A in?

BOL-303224-A is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not received FDA approval and is still in the early stages of clinical testing for bacterial conjunctivitis.

What clinical trials is BOL-303224-A in?

BOL-303224-A has one completed Phase 1 clinical trial registered as NCT00407589, titled "Systemic Pharmacokinetics of BOL-303224-A." The trial enrolled 24 participants in the United States and studied the drug's systemic exposure in patients with bacterial conjunctivitis.

Is BOL-303224-A FDA approved?

No, BOL-303224-A is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for bacterial conjunctivitis. A Phase 1 trial has been completed, but the drug has not yet progressed to later-stage trials or received regulatory approval.