NCT00331916

Brief Summary

The purpose of the study is to determine whether AL-15469A is safe and effective in the treatment of bacterial conjunctivitis.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Last Updated

September 29, 2009

Status Verified

September 1, 2009

Enrollment Period

1.5 years

First QC Date

May 30, 2006

Last Update Submit

September 25, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical cure and microbiological success

Secondary Outcomes (1)

  • Individual signs and symptoms of bacterial conjunctivitis at each visit

Interventions

Eligibility Criteria

Age1 Month+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Signs \& Symptoms of conjunctivitis

You may not qualify if:

  • Under 1 mo. age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

US

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

Quinolones

Condition Hierarchy (Ancestors)

Eye Infections, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsEye InfectionsConjunctivitisConjunctival DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

QuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Stella Robertson, Ph.D.

    Study Director

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2006

First Posted

May 31, 2006

Study Start

November 1, 2005

Primary Completion

May 1, 2007

Last Updated

September 29, 2009

Record last verified: 2009-09

Locations