NCT01238783

Brief Summary

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

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

December 1, 2011

Status Verified

November 1, 2011

Enrollment Period

11 months

First QC Date

November 9, 2010

Last Update Submit

November 29, 2011

Conditions

Bacterial Conjunctivitis

Outcome Measures

Primary Outcomes (2)

  • Sustained Clinical Cure rate

    Day 3

  • End of therapy Clinical Cure rate

    Day 4

Secondary Outcomes (2)

  • Sustained bulbar conjunctival injection

    Day 3

  • Microbiological Success

    Day 4

Study Arms (4)

AL-15469A 0.5% and AL-65150.3% Ophthalmic Suspension

EXPERIMENTAL
Drug: AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension

AL-15469A 0.5%

EXPERIMENTAL
Drug: AL-15469A 0.5%

AL-6515 0.3%

EXPERIMENTAL
Drug: AL-6515 0.3%

Vehicle

PLACEBO COMPARATOR
Drug: Vehicle

Interventions

AL-15469A 0.5% and AL-6515 0.3% Ophthalmic SuspensionDRUG

Topical ocular dosed 3 times per day for 3 days

AL-15469A 0.5% and AL-65150.3% Ophthalmic Suspension
AL-15469A 0.5%DRUG

Topical ocular dosed 3 times per day for 3 days

AL-15469A 0.5%
AL-6515 0.3%DRUG

Topical ocular dosed 3 times per day for 3 days

AL-6515 0.3%
VehicleDRUG

Topical ocular dosed 3 times per day for 3 days

Vehicle

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Condition Hierarchy (Ancestors)

Eye Infections, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsEye InfectionsConjunctivitisConjunctival DiseasesEye Diseases
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2010

First Posted

November 11, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Last Updated

December 1, 2011

Record last verified: 2011-11