MedDataX Logo

Effectiveness Study of Zymar Versus Vigamox for Preoperative Sterilization of the Ocular Surface After Loading Dose

NCT ID: NCT00347828

Last Updated: 2006-07-04

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2006-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to analyze the effect of Zymar and Vigamox on ocular surface bacteria. We believe that Zymar will eradicate more ocular surface bacteria than Vigamox.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Topical antibiotics are frequently used before surgical procedures with the intent of targetting and reducing the number of bacteria on the surface of the eye. These bacteria serve as potential sources for post-operative infection. One commonly used method is the administration of antibiotic drops 3 times: 1 hour prior to surgery at intervals of 5 minutes. Studies in the lab have shown that the preservative benzalkonium chloride 0.005%, part of the Zymar antibiotic drop preparation, allows the antibiotic to act more effectively than the antibiotic Vigamox, which does not include this preservative.

Comparison: The effect of Zymar antibiotic eye drops on conjunctival cultures compared to the effect of Vigamox on conjunctival cultures as measured by conjunctival cultures taken prior to treatment and then one hour after administration of eye drops 3 times, at 5 minute intervals.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Eye Infection Infection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Antibiotic prophylaxis Vigamox Moxifloxacin Zymar Gatifloxacin Preoperative antibiotic Eye infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Moxifloxacin ophthalmic solution 0.5%

Intervention Type DRUG

Gatifloxacin ophthalmic solution 0.3%

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female 25 years of age or older
* Informed consent
* Likely to complete the entire course of the study

Exclusion Criteria

* Contraindications or known sensitivity to any component of the study medications
* A subject on oral or topical antibiotics
* A subject that has a condition (i.e. an uncontrolled systemic disease) or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound the trial results, or may interfere significantly with the subject's participation in the trial.
* Monocular subjects
* Contact lens wearers
* Subjects who regularly take eyedrops other than preservative free artificial tears
* A subject with an eye infection
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Allergan

INDUSTRY

Sponsor Role collaborator

Ophthalmic Consultants of Boston

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael B Raizman, B.A./M.D.

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants of Boston

Sandra Y Cho, B.A./M.D.

Role: STUDY_DIRECTOR

New England Eye Center/Tufts-New England Medical Center

Rahul Mandiga, B.S.

Role: STUDY_DIRECTOR

New England Eye Center/Tufts-New England Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Allergan/Z101

Identifier Type: -

Identifier Source: org_study_id