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

Phase 2TerminatedNCT00579020

Alcon Research144 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

144

Conditions

Corneal Infiltrates

Interventions

Moxifloxacin/dexamethasone phosphate ophthalmic solutionDRUG

Moxifloxacin ophthalmic solution 0.5%DRUG

Dexamethasone phosphate solution, 0.1%DRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: Day 10

Secondary Outcomes

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

Time frame: Day 10

Data from ClinicalTrials.gov

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