Safety of NGOIS Compared to BSS Plus in Pediatric Patients

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

Completed

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

1 week–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Contact Alcon for Trial Locations

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

Cataract present.
Other protocol-defined inclusion criteria may apply.

Exclusion criteria

As per age requirements.
Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Next Generation Ophthalmic Irrigating Solution (NGOIS)

Drug

Volume sufficient to irrigate adequately during cataract surgery

BSS Plus

Drug

Volume sufficient to irrigate adequately during cataract surgery

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Jun 30, 2006
Registry last updated: Mar 5, 2012

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