Next Generation Ophthalmic Irrigating Solution Posterior Segment Study

Phase 3

Completed

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

• Registration Number: NCT00333203
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2006-03
• Study Completion: 2006-03
• 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 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 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
Best-corrected logMAR visual acuity

Secondary Outcome Measures

Name	Time	Method
Intraocular pressure (IOP)

Trial Locations

Locations (1)

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