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

Corneal Infiltrates Clinical Trial

Official title:

An Evaluation of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00579020
• Other study ID #: C-05-04
• Status: Terminated
• Phase: Phase 2
• First received: December 19, 2007
• Last updated: December 3, 2012
• Start date: December 2007
• Est. completion date: February 2009

Study information

• Verified date: December 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 144
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Infiltrates

Intervention

Drug:
• Moxifloxacin/dexamethasone phosphate ophthalmic solution

• Moxifloxacin ophthalmic solution 0.5%

• Dexamethasone phosphate solution, 0.1%

Locations

Country	Name	City	State
United States	Contact Alcon Call Center at 1-888-451-3937	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with resolution of all corneal stromal infiltrate(s) in study eye at Test of Cure (TOC) Visit (Day 10)		Day 10	No
Secondary	Percentage of patients with eradication of pre-therapy pathogens from the lid of the study eye at TOC Visit (Day 10)		Day 10	No