Safety of NGOIS Compared to BSS Plus in Pediatric Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00346528

Enrollment

Registered

2006-06-30

Start date

2006-07-31

Completion date

2007-06-30

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

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

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

1 Weeks to 17 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* As per age requirements. * Other protocol-defined

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

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