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AL-15469A for the Treatment of Bacterial Conjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00332293
First received: May 31, 2006
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Clinical cure and microbiological success

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

Enrollment: 695
Study Start Date: May 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Month and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332293

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00332293     History of Changes
Other Study ID Numbers: C-04-40
Study First Received: May 31, 2006
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013