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

Bacterial Conjunctivitis Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01238783
• Other study ID #: C-09-061
• Status: Withdrawn
• Phase: Phase 2
• First received: November 9, 2010
• Last updated: November 29, 2011
• Start date: January 2011

Study information

• Verified date: November 2011
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bacterial Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Bacterial

Intervention

Drug:
• AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension
Topical ocular dosed 3 times per day for 3 days
• AL-15469A 0.5%
Topical ocular dosed 3 times per day for 3 days
• AL-6515 0.3%
Topical ocular dosed 3 times per day for 3 days
• Vehicle
Topical ocular dosed 3 times per day for 3 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Clinical Cure rate		Day 3	No
Primary	End of therapy Clinical Cure rate		Day 4	Yes
Secondary	Sustained bulbar conjunctival injection		Day 3	Yes
Secondary	Microbiological Success		Day 4	No