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Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01238783
First received: November 9, 2010
Last updated: November 29, 2011
Last verified: November 2011
History of Changes
  Purpose

To assess safety and efficacy of AL-15469A 0.5% /AL-6515 0.3% Ophthalmic Suspension for treatment of bacterial conjunctivitis


Condition Intervention Phase
Bacterial Conjunctivitis
 Drug: AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension
Drug: AL-15469A 0.5%
Drug: AL-6515 0.3%
Drug: Vehicle
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Sustained Clinical Cure rate [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • End of therapy Clinical Cure rate [ Time Frame: Day 4 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Sustained bulbar conjunctival injection [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
  • Microbiological Success [ Time Frame: Day 4 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-15469A 0.5% and AL-65150.3% Ophthalmic Suspension Drug: AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension
Topical ocular dosed 3 times per day for 3 days
Experimental: AL-15469A 0.5% Drug: AL-15469A 0.5%
Topical ocular dosed 3 times per day for 3 days
Experimental: AL-6515 0.3% Drug: AL-6515 0.3%
Topical ocular dosed 3 times per day for 3 days
Placebo Comparator: Vehicle Drug: Vehicle
Topical ocular dosed 3 times per day for 3 days

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients of any race
  • 5 years of age and older at the time of the Day 1 visit
  • with a primary clinical diagnosis of bacterial conjunctivitis.

Exclusion Criteria:

  • Onset of bacterial conjunctivitis (signs and symptoms) more than 4 days
  • Presence of punctal plug or punctal occlusion
  • Visual Acuity worse than 20/80
  • Upper respiratory infection
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01238783     History of Changes
Other Study ID Numbers: C-09-061
Study First Received: November 9, 2010
Last Updated: November 29, 2011
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 May 19, 2013