A Phase II Study of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates
This study has been terminated.
(Management decision)
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00579020
First received: December 19, 2007
Last updated: December 3, 2012
Last verified: December 2012
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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: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | An Evaluation of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone phosphate
Dexamethasone acetate
Dexamethasone sodium phosphate
Moxifloxacin
Moxifloxacin hydrochloride
U.S. FDA Resources
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
| 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| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| 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 More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT00579020 History of Changes |
| Other Study ID Numbers: | C-05-04 |
| Study First Received: | December 19, 2007 |
| Last Updated: | December 3, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Alcon Research:
|
cornea inflammation blepharitis lid infection |
Additional relevant MeSH terms:
|
Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Moxifloxacin Norgestimate, ethinyl estradiol drug combination Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents 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-Infective Agents Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on June 18, 2013