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

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01238783
Enrollment
0
Registered
2010-11-11
Start date
2011-01-31
Completion date
Unknown
Last updated
2011-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Conjunctivitis

Brief summary

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

Interventions

DRUGAL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension

Topical ocular dosed 3 times per day for 3 days

DRUGAL-15469A 0.5%

Topical ocular dosed 3 times per day for 3 days

DRUGAL-6515 0.3%

Topical ocular dosed 3 times per day for 3 days

DRUGVehicle

Topical ocular dosed 3 times per day for 3 days

Sponsors

Alcon Research
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Sustained Clinical Cure rateDay 3
End of therapy Clinical Cure rateDay 4

Secondary

MeasureTime frame
Sustained bulbar conjunctival injectionDay 3
Microbiological SuccessDay 4

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026