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Systemic Pharmacokinetics of BOL-303224-A

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Bausch + Lomb

Status and phase

Completed
Phase 1

Conditions

Conjunctivitis, Bacterial

Treatments

Drug: BOL-303224-A

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

This is a multi-center, open-label, single dose/multiple dose, pharmacokinetic study in participants with bacterial conjunctivitis. The purpose of this study is to determine the extent of systemic exposure to BOL-303224-A following single and multiple topical administration of BOL-303224-A in participants with suspected bacterial conjunctivitis.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 pregnancy test

Exclusion criteria

  • Pregnant or nursing women
  • known hypersensitivity to fluoroquinolones or to any of the ingredients in the study medication
  • use of any antibiotic within 72 hours of enrollment
  • participation in an ophthalmic drug or devise research study within 30 days prior to entry in this study

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

BOL-303224-A
Experimental group
Description:
Systemic exposure of BOL-303224-A following single and multiple topical doses
Treatment:
Drug: BOL-303224-A

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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