Brief Summary

The purpose of the study is to determine whether Moxidex ophthalmic solution is safe and effective in treating marginal corneal infiltrates.

Trial Health

Monitor

Trial Health Score

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

Enrollment

144

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Dec 2007

Shorter than P25 for phase_2

Geographic Reach

1 country

1 active site

Status

terminated

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

1.2 years study duration

Study Start

First participant enrolled

December 1, 2007

Completed

18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2007

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed

Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

1.2 years

First QC Date

December 19, 2007

Last Update Submit

December 3, 2012

Conditions

Corneal Infiltrates

Keywords

corneainflammationblepharitislid infection

Outcome Measures

Primary Outcomes (1)

Percentage of patients with resolution of all corneal stromal infiltrate(s) in study eye at Test of Cure (TOC) Visit (Day 10)
Day 10

Secondary Outcomes (1)

Percentage of patients with eradication of pre-therapy pathogens from the lid of the study eye at TOC Visit (Day 10)
Day 10

Study Arms (3)

Moxidex

EXPERIMENTAL

Moxifloxacin/dexamethasone phosphate ophthalmic solution, one drop in cul-de-sac and 4 drops on closed lids of study eye(s), four times a day, for seven days

Drug: Moxifloxacin/dexamethasone phosphate ophthalmic solution

Moxifloxacin

ACTIVE COMPARATOR

Moxifloxacin ophthalmic solution 0.5%, one drop in cul-de-sac and 4 drops on closed lids of study eye(s), four times a day, for seven days

Drug: Moxifloxacin ophthalmic solution 0.5%

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone phosphate solution, 0.1%, one drop in cul-de-sac and 4 drops on closed lids of study eye(s), four times a day, for seven days

Drug: Dexamethasone phosphate solution, 0.1%

Interventions

Moxifloxacin/dexamethasone phosphate ophthalmic solutionDRUG

Also known as: Moxidex

Moxidex

Moxifloxacin ophthalmic solution 0.5%DRUG

Moxifloxacin

Dexamethasone phosphate solution, 0.1%DRUG

Dexamethasone

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of marginal corneal infiltrates of size equal to or less than 1.5mm in diameter, with mild, moderate or severe bulbar conjunctival injection in at least one eye.

You may not qualify if:

Age related.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Alcon Researchlead

Study Sites (1)

Contact Alcon Call Center at 1-888-451-3937

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Corneal DiseasesInflammationBlepharitis

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Eye DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEyelid Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

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

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 21, 2007

Study Start

December 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations

US(1)

Study Stopped

A Phase II Study of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

Moxidex

Moxifloxacin

Dexamethasone

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

Moxidex

Moxifloxacin

Dexamethasone

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

Locations