AL-15469A for the Treatment of Bacterial Conjunctivitis

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00331916
First received: May 30, 2006
Last updated: September 25, 2009
Last verified: September 2009
  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: quinolone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: AL-15469A for the Treatment of Bacterial Conjunctivitis

Resource links provided by NLM:


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

Estimated Enrollment: 600
Study Start Date: November 2005
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   1 Month and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signs & Symptoms of conjunctivitis

Exclusion Criteria:

  • Under 1 mo. age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331916

Locations
United States, Texas
US
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Stella Robertson, Ph.D. Study Director
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00331916     History of Changes
Other Study ID Numbers: C-04-38
Study First Received: May 30, 2006
Last Updated: September 25, 2009
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

ClinicalTrials.gov processed this record on September 18, 2014