NCT00332293

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

87
On Track

Trial Health Score

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

Enrollment
695

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2006

Shorter than P25 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

May 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

November 18, 2016

Status Verified

March 1, 2012

Enrollment Period

7 months

First QC Date

May 31, 2006

Last Update Submit

November 16, 2016

Conditions

Bacterial Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Clinical cure and microbiological success

Secondary Outcomes (1)

  • Individual signs and symptoms of bacterial conjunctivitis at each visit

Study Arms (2)

Moxifloxacin

EXPERIMENTAL
Drug: Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5%

VIGAMOX

ACTIVE COMPARATOR
Drug: Moxifloxacin hydrochloride ophthalmic solution 0.5% as base

Interventions

Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5%DRUG

1 drop into the conjunctival sac of both eyes 3 times a day for 3 days

Moxifloxacin
Moxifloxacin hydrochloride ophthalmic solution 0.5% as baseDRUG

1 drop into the conjunctival sac of both eyes 3 times a day for 3 days

Also known as: VIGAMOX
VIGAMOX

Eligibility Criteria

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

You may qualify if:

  • signs and symptoms of bacterial conjunctivitis

You may not qualify if:

  • under 1 mo. age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon for Trial Locations

Fort Worth, Texas, 76134, United States

Location

Related Publications (1)

  • Tauber S, Cupp G, Garber R, Bartell J, Vohra F, Stroman D. Microbiological efficacy of a new ophthalmic formulation of moxifloxacin dosed twice-daily for bacterial conjunctivitis. Adv Ther. 2011 Jul;28(7):566-74. doi: 10.1007/s12325-011-0037-x. Epub 2011 Jun 14.

    PMID: 21681652RESULT

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

AlkaliesMoxifloxacin

Condition Hierarchy (Ancestors)

Eye Infections, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsEye InfectionsConjunctivitisConjunctival DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Inorganic ChemicalsFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2006

First Posted

June 1, 2006

Study Start

May 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

November 18, 2016

Record last verified: 2012-03

Locations

US(1)