Conjunctical Flora Clinical Trial
Official title:
Prospective Randomized Comparison of Zymar(Gatifloxacin) and Vigamox (Moxifloxacin) in Killing Conjunctival Bacterial Flora Following a One-hour
| NCT number | NCT00466570 |
| Other study ID # | 8924 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | N/A |
| First received | April 25, 2007 |
| Last updated | June 12, 2013 |
| Start date | April 2007 |
| Verified date | June 2013 |
| Source | Stanford University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
Topical ophthalmic antibiotics are common prescribed just prior to eye surgery to lower the risk of infection. Previous studies have suggested that antibiotics containing a preservative (Zymar) kill bacteria much quicker than those without a preservative (Vigamox). The purpose of this research is to compare how quickly to the two commonly prescribed antibiotics eliminate bacteria from the eye surface.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
Inclusion Criteria: - Age- older than 50 years of age - Diagnosis- Cataract or had cataract surgery Exclusion Criteria: - Systemic or topical antibiotic treatment within 30 days - Use of systemic or topical steroids - Active ocular infection - Ocular surgery in the past 6 months - Allergy to fluoroquinolones |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Stanford University |
de Kaspar HM, Kreidl KO, Singh K, Ta CN. Comparison of preoperative conjunctival bacterial flora in patients undergoing glaucoma or cataract surgery. J Glaucoma. 2004 Dec;13(6):507-9. — View Citation
Miño de Kaspar H, Koss MJ, He L, Blumenkranz MS, Ta CN. Antibiotic susceptibility of preoperative normal conjunctival bacteria. Am J Ophthalmol. 2005 Apr;139(4):730-3. — View Citation
Ta CN, Chang RT, Singh K, Egbert PR, Shriver EM, Blumenkranz MS, Miño de Kaspar H. Antibiotic resistance patterns of ocular bacterial flora: a prospective study of patients undergoing anterior segment surgery. Ophthalmology. 2003 Oct;110(10):1946-51. — View Citation
Ta CN, Egbert PR, Singh K, Shriver EM, Blumenkranz MS, Miño De Kaspar H. Prospective randomized comparison of 3-day versus 1-hour preoperative ofloxacin prophylaxis for cataract surgery. Ophthalmology. 2002 Nov;109(11):2036-40; discussion 2040-1. — View Citation
Ta CN, He L, Nguyen E, De Kaspar HM. Prospective randomized study determining whether a 3-day application of ofloxacin results in the selection of fluoroquinolone-resistant coagulase-negative Staphylococcus. Eur J Ophthalmol. 2006 May-Jun;16(3):359-64. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Antibiotic killing of conjunctival bacterial flora 1 hour after application |