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

Phase 2

Terminated

• Conditions: Corneal Infiltrates
• Interventions: Drug: Moxifloxacin/dexamethasone phosphate ophthalmic solution; Drug: Moxifloxacin ophthalmic solution 0.5%; Drug: Dexamethasone phosphate solution, 0.1%

• Registration Number: NCT00579020
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-21
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2012-12
• Disposition First Submitted: 2012-12-03
• Disposition First Submitted QC: 2012-12-03
• Last Update Submitted: 2012-12-03
• Disposition First Posted: 2012-12-05
• Last Update Posted: 2012-12-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• 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.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Age related.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxidex	Moxifloxacin/dexamethasone phosphate ophthalmic solution	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
Moxifloxacin	Moxifloxacin ophthalmic solution 0.5%	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
Dexamethasone	Dexamethasone phosphate solution, 0.1%	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Contact Alcon Call Center at 1-888-451-3937; 🇺🇸 Fort Worth, Texas, United States