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

NCT ID: NCT00579020

Last Updated: 2012-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-02-28

Brief Summary

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

Detailed Description

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Conditions

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Corneal Infiltrates

Keywords

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cornea inflammation blepharitis lid infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Moxidex

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

Group Type EXPERIMENTAL

Moxifloxacin/dexamethasone phosphate ophthalmic solution

Intervention Type DRUG

Moxifloxacin

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

Group Type ACTIVE_COMPARATOR

Moxifloxacin ophthalmic solution 0.5%

Intervention Type DRUG

Dexamethasone

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

Group Type ACTIVE_COMPARATOR

Dexamethasone phosphate solution, 0.1%

Intervention Type DRUG

Interventions

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Moxifloxacin/dexamethasone phosphate ophthalmic solution

Intervention Type DRUG

Moxifloxacin ophthalmic solution 0.5%

Intervention Type DRUG

Dexamethasone phosphate solution, 0.1%

Intervention Type DRUG

Other Intervention Names

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Moxidex

Eligibility Criteria

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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.

Exclusion Criteria

* Age related.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C-05-04

Identifier Type: -

Identifier Source: org_study_id