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

Alcon

Status and phase: Terminated; Phase 2

Conditions: Corneal Infiltrates

Treatments: Drug: Moxifloxacin/dexamethasone phosphate ophthalmic solution; Drug: Dexamethasone phosphate solution, 0.1%; Drug: Moxifloxacin ophthalmic solution 0.5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00579020

C-05-04

Details and patient eligibility

About

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

Enrollment: 144 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 3 patient groups

Moxidex

Experimental group

Description:

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

Treatment:

Drug: Moxifloxacin/dexamethasone phosphate ophthalmic solution

Moxifloxacin

Active Comparator group

Description:

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

Treatment:

Drug: Moxifloxacin ophthalmic solution 0.5%

Dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone phosphate solution, 0.1%