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

This study has been terminated.
(Management decision)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00579020
First Posted: December 21, 2007
Last Update Posted: December 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  Purpose
The purpose of the study is to determine whether Moxidex ophthalmic solution is safe and effective in treating marginal corneal infiltrates.

Condition Intervention Phase
Corneal Infiltrates Drug: Moxifloxacin/dexamethasone phosphate ophthalmic solution Drug: Moxifloxacin ophthalmic solution 0.5% Drug: Dexamethasone phosphate solution, 0.1% Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: An Evaluation of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 144
Study Start Date: December 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: Moxifloxacin/dexamethasone phosphate ophthalmic solution
Other Name: Moxidex
Active Comparator: 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
Drug: Moxifloxacin ophthalmic solution 0.5%
Active Comparator: 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
Drug: Dexamethasone phosphate solution, 0.1%

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579020


Locations
United States, Texas
Contact Alcon Call Center at 1-888-451-3937
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00579020     History of Changes
Other Study ID Numbers: C-05-04
First Submitted: December 19, 2007
First Posted: December 21, 2007
Last Update Posted: December 5, 2012
Last Verified: December 2012

Keywords provided by Alcon Research:
cornea
inflammation
blepharitis
lid infection

Additional relevant MeSH terms:
Pharmaceutical Solutions
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Moxifloxacin
BB 1101
Fluoroquinolones
Ophthalmic Solutions
Norgestimate, ethinyl estradiol drug combination
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female