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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alcon Call Center

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

1 drop every 6 hours into the study eye

Primary outcomes

The Percentage of Patients With a Score of Zero for Anterior Chamber Cells.

Time frame: Day 15 after cataract surgery

The percentage of patients with a score of zero for Anterior chamber cells.

Anterior chamber inflammation was evaluated based on the number of cells per high-power field measured using the narrowest slit beam of the lamp (0.5 at a height of 8mm).

Anterior chamber cells was recorded on a 0-4 point scale,0 = Less than 5 cells; 1 = Mild: 5-10 cells; 2 = Moderate:11-20 cells; 3 = Marked: 21-50 cells; 4 = Severe: Greater than 50 cells / hypopyon
The Percentage of Patients With no Ocular Pain

Time frame: Day 15 after cataract surgery

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

An Evaluation of the Prophylactic Efficacy and Safety of the Administration of the Combination Formulation of Moxifloxacin 0.5% and Dexamethasone 0.1% Eye Drops in Inflammation and Infection Post-cataract Surgery

Important dates

Study start: 2008
Primary completion: 2009
First posted: Mar 26, 2009
Registry last updated: Mar 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed