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Trial record 68 of 76 for:    "Bacterial Infectious Disease" | "Polyestradiol phosphate"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00348348
Recruitment Status : Completed
First Posted : July 4, 2006
Results First Posted : August 13, 2009
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

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

Condition or disease Intervention/treatment Phase
Acute Bacterial Conjunctivitis Drug: Besifloxacin Drug: Moxifloxacin solution Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vigamox in the Treatment of Bacterial Conjunctivitis
Study Start Date : June 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
Active Comparator: Moxifloxacin solution
Moxifloxacin hydrochloride ophthalmic solution 0.5%
Drug: Moxifloxacin solution
Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days.

Experimental: Besifloxacin Suspension
Besifloxacin hydrochloride ophthalmic suspension 0.6%
Drug: Besifloxacin
Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days




Primary Outcome Measures :
  1. Clinical Resolution [ Time Frame: Day 5(+/- 1 day) ]
    Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)

  2. Microbial Eradication [ Time Frame: Day 5 (+/- 1 day) ]
    eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated


Secondary Outcome Measures :
  1. Clinical Resolution [ Time Frame: Day 8 or Day 9 ]
    Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated

  2. Microbial Eradication [ Time Frame: Day 8 or Day 9 ]
    Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated



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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348348


Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Study Director: Timothy Comstock, OD Bausch & Lomb Incorporated

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00348348     History of Changes
Other Study ID Numbers: 434
First Posted: July 4, 2006    Key Record Dates
Results First Posted: August 13, 2009
Last Update Posted: March 24, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
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Bacterial Infections
Norgestimate, ethinyl estradiol drug combination
Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Eye Infections
Infection
Pharmaceutical Solutions
Ophthalmic Solutions
Moxifloxacin
Besifloxacin
Fluoroquinolones
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors