Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis

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Bausch + Lomb

Status and phase

Completed
Phase 3
Phase 2

Conditions

Bacterial Conjunctivitis

Treatments

Drug: Vehicle (Placebo)
Drug: Besifloxacin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00972777
603

Details and patient eligibility

About

This study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis. This study was conducted as a phase IIb study and continued with further enrollment as a phase III study.

Enrollment

474 patients

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects who are at least one year of age.
  • Subjects who have a clinical diagnosis of acute bacterial conjunctivitis.
  • Subjects who are willing to discontinue contact lens wear for the duration of the study.

Exclusion criteria

  • Subjects who have any uncontrolled systemic disease or debilitating disease.
  • Subjects with known sensitivity or contraindications to besifloxacin, fluoroquinolones or any ingredients in study drugs.
  • Subjects who are expected to require treatment with any disallowed medications.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

474 participants in 2 patient groups, including a placebo group

Besifloxacin
Experimental group
Description:
0.6% ophthalmic suspension
Treatment:
Drug: Besifloxacin
Vehicle
Placebo Comparator group
Treatment:
Drug: Vehicle (Placebo)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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