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This study has been withdrawn prior to enrollment.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
  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:


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
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.

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 July 31, 2014