Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus

Phase 3

Completed

• Conditions: Cataract
• Interventions: Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS); Drug: BSS Plus

• Registration Number: NCT00333268
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to determine the safety and efficacy of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS Plus for use during cataract extraction and intra-ocular lens (IOL) implantation.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2006-06-01
• Study First Submitted QC: 2006-06-01
• Study First Posted: 2006-06-02
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-01
• Last Update Posted: 2012-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 369

Inclusion Criteria

• Patients any race or sex 18 or older and undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Under 18
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NGOIS	Next Generation Ophthalmic Irrigating Solution (NGOIS)	-
BSS Plus	BSS Plus	-

Primary Outcome Measures

Name	Time	Method
Percent change in endothelial cell density

Secondary Outcome Measures

Name	Time	Method
Best corrected logMAR visual acuity

Trial Locations

Locations (1)

United States; 🇺🇸 Fort Worth, Texas, United States