Dosage Study for Vigamox Eye Drops Prior to Intravitreal Injections
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Illinois Retina Associates.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Illinois Retina Associates
Collaborator:
Alcon Research
Information provided by:
Illinois Retina Associates
ClinicalTrials.gov Identifier:
NCT00690313
First received: May 30, 2008
Last updated: June 3, 2008
Last verified: May 2008
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Purpose
Antibiotic eye drops are being used before and after intravitreal injections. Currently there is no study indicating the benefit of there usage or their dosage.
In this study we compare the efficacy of Vigamox eye drops (antibiotic)starting 3 days prior to the injection versus 1 day prior to intravitreal injection.
| Condition | Intervention | Phase |
|---|---|---|
|
Intravitreal Injection Patients |
Drug: Vigamox |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | To Compare the Efficacy of Topical Vigamox Eye Drops at Tid 3 Days Prior to Intravitreal Injection Versus Tid 1 Day Prior to Intravitreal Injection |
Resource links provided by NLM:
Drug Information available for:
Tetrahydrozoline hydrochloride
Boric acid
Moxifloxacin
Moxifloxacin hydrochloride
U.S. FDA Resources
Further study details as provided by Illinois Retina Associates:
Primary Outcome Measures:
- Timed study [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1
Arm 1: receives Vigamox eye drops 3Xday for 3 days prior to intravitreal injection
|
Drug: Vigamox
eye drops 3 times day either 1 or 3 days prior to intravitreal injection
|
|
Active Comparator: Arm 2
Arm 2: receives Vigamox eye drops 3Xday for 1 day prior to intravitreal injection
|
Drug: Vigamox
eye drops 3 times day either 1 or 3 days prior to intravitreal injection
|
Eligibility| Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient who need intravitreal injections patients who are willing to participate in the study
Exclusion Criteria:
- Patients who are allergic to Vigamox or who have taken any eye drops within the past 3 weeks
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690313
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690313
Contacts
| Contact: Kourous A Rezaei, MD | 708-596-8710 | karezaei@yahoo.com | |
| Contact: David J Baczewski | 708-915-6808 | davidb@illinoisretina.com |
Locations
| United States, Illinois | |
| Illinois Retina Associates | Not yet recruiting |
| Harvey, Illinois, United States, 60426 | |
| Contact: David J Baczewski 708-915-6808 davidb@illinoisretina.com | |
| Principal Investigator: Kourous A Rezaei, MD | |
Sponsors and Collaborators
Illinois Retina Associates
Alcon Research
Investigators
| Principal Investigator: | Kourous A Rezaei, MD | Illinois Retina Associates SC |
More Information
| Responsible Party: | Kourous Rezaei MD, Illinois Retina Associates SC |
| ClinicalTrials.gov Identifier: | NCT00690313 History of Changes |
| Other Study ID Numbers: | Vig508 |
| Study First Received: | May 30, 2008 |
| Last Updated: | June 3, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Illinois Retina Associates:
|
Vigamox, topical antibiotics, Intravitreal injections, macular degeneration, endophthalmitis |
Additional relevant MeSH terms:
|
Ophthalmic Solutions Tetrahydrozoline Norgestimate, ethinyl estradiol drug combination Moxifloxacin Fluoroquinolones Pharmaceutical Solutions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Nasal Decongestants Vasoconstrictor Agents Respiratory System Agents |
Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on September 29, 2016