Safety of NGOIS Compared to BSS Plus in Pediatric Patients

This study has been completed.

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00346528

Purpose

To evaluate the Safety of Next Generation Ophthalmic Irrigating Solution compared to BSS Plus for use during cataract surgery in Pediatric patients.

Condition	Intervention	Phase
Cataract	Drug: Next Generation Ophthalmic Irrigating Solution	Phase III

MedlinePlus related topics: Cataract

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:	Safety of NGOIS Compared to BSS Plus in Pediatric Patients

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Safety Variables: Endothelial cell density, visual acuity, intraocular pressure, ocular signs and fundus assessment

Estimated Enrollment:	20
Study Start Date:	July 2006

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346528

Locations

United States, Texas
Riley Outpatient Center
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

Investigators

Study Director:

Stephen Lane

Medical Monitor

More Information

Study ID Numbers:	C-04-64
Study First Received:	June 28, 2006
Last Updated:	June 25, 2007
ClinicalTrials.gov Identifier:	NCT00346528
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on January 14, 2009