Next Generation Ophthalmic Irrigating Solution Posterior Segment Study

Clinical Evaluation of the Safety of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus for Use During Surgery for Removal of Epimacular Membrane and Vitrectomy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00333203

Enrollment

369

Registered

2006-06-02

Start date

2005-10-31

Completion date

2006-03-31

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

Eye Diseases

Keywords

epimacular membrane

Brief summary

The purpose of this study is to evaluate the safety of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS PLUS for use during surgery for removal of epimacular membrane and vitrectomy.

Interventions

DRUGNext Generation Ophthalmic Irrigating Solution (NGOIS)

Volume sufficient to irrigate adequately during cataract surgery

OTHERBSS Plus

Volume sufficient to irrigate adequately during cataract surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients of any race and sex, with an epimacular membrane who would benefit from vitrectomy and membrane removal. * Other protocol-defined inclusion criteria may apply.

Exclusion criteria

* Under 18 years of age. * Other protocol-defined

Design outcomes

Primary

Measure	Time frame
Best-corrected logMAR visual acuity	—

Secondary

Measure	Time frame
Intraocular pressure (IOP)	—

Countries

United States

Outcome results

None listed

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