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

Clinical Evaluation of the Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus for Use During Cataract Extraction and IOL Implantation

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00333268

Enrollment

369

Registered

2006-06-02

Start date

2004-09-30

Completion date

2005-07-31

Last updated

2012-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

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.

Interventions

DRUGNext Generation Ophthalmic Irrigating Solution (NGOIS)

Volume sufficient to irrigate adequately during cataract surgery

DRUGBSS Plus

Volume sufficient to irrigate adequately during cataract surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percent change in endothelial cell density	—

Secondary

Measure	Time frame
Best corrected logMAR visual acuity	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026