Study of Efficacy and Safety of Vigadexa in Treating Inflammation and Infection Post-cataract Surgery

NCT ID: NCT00870103

Last Updated: 2010-03-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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To demonstrate that the combination formulation of Moxifloxacin/Dexamethasone Eye Drop is effective and safe for the prevention of postoperative inflammation as a consequence of cataract extraction surgery.

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vigadexa eye drops

Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops

Group Type EXPERIMENTAL

Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops

Intervention Type DRUG

1 drop every 6 hours into the study eye

Interventions

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Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops

1 drop every 6 hours into the study eye

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ≧18 years of age
* able to sign an informed consent and complete all required visits
* intends to have a cataract extraction surgery followed by implantation of a posterior chamber Intraocular lens (IOL)
* Intraocular Pressure (IOP) ≦ 20 millimeters mercury (mmHg)

Exclusion Criteria

* Uncontrolled glaucoma or IOP
* use of ocular anti-infectious during the study and within 30 days prior to the enrollment, secondary implantation or replacement of IOL in the study eye
* use of steroid during the study or within 14 days prior to enrollment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Alcon Research Ltd.

Locations

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Alcon Call Center

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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RM-08-05

Identifier Type: -

Identifier Source: org_study_id

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