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AL-15469A for 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: NCT00332293
Recruitment Status : Completed
First Posted : June 1, 2006
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
The purpose of the study is to determine whether AL-15469A is safe and effective in the treatment of bacterial conjunctivitis.

Condition or disease Intervention/treatment Phase
Bacterial Conjunctivitis Drug: Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5% Drug: Moxifloxacin hydrochloride ophthalmic solution 0.5% as base Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 695 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Evaluation of the Safety and Efficacy of Moxifloxacin AF Ophthalmic Solution 0.5% for the Treatment of Bacterial Conjunctivitis in India
Study Start Date : May 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arms and Interventions
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Arm Intervention/treatment
Experimental: Moxifloxacin Drug: Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5%
1 drop into the conjunctival sac of both eyes 3 times a day for 3 days
Active Comparator: VIGAMOX Drug: Moxifloxacin hydrochloride ophthalmic solution 0.5% as base
1 drop into the conjunctival sac of both eyes 3 times a day for 3 days
Other Name: VIGAMOX


Outcome Measures
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Primary Outcome Measures :
  1. Clinical cure and microbiological success

Secondary Outcome Measures :
  1. Individual signs and symptoms of bacterial conjunctivitis at each visit

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

Inclusion Criteria:

  • signs and symptoms of bacterial conjunctivitis
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • under 1 mo. age
  • Other protocol-defined exclusion criteria may apply
Contacts and Locations
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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): NCT00332293


Locations
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United States, Texas
Contact Alcon for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
More Information
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Publications of Results:

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00332293    
Other Study ID Numbers: C-04-40
First Posted: June 1, 2006    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: March 2012
Additional relevant MeSH terms:
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Conjunctivitis, Bacterial
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Moxifloxacin
Ophthalmic Solutions
Norgestimate, ethinyl estradiol drug combination
Pharmaceutical Solutions
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