Next Generation Ophthalmic Irrigating Solution Posterior Segment Study

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00333203
• Collaborator: (none)
• Enrollment: 369
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 74.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eye Diseases	Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS); Other: BSS Plus	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 369 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Mar 1, 2006
• Actual Study Completion Date: Mar 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NGOIS	Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS); Volume sufficient to irrigate adequately during cataract surgery
Active Comparator: BSS Plus	Other: BSS Plus; Volume sufficient to irrigate adequately during cataract surgery

Outcome Measures

Primary Outcome Measures

1. Best-corrected logMAR visual acuity []

Secondary Outcome Measures

1. Intraocular pressure (IOP) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	United States	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00333203
• Other Study ID Numbers: C-04-18
• First Posted: Jun 2, 2006
• Last Update Posted: Mar 5, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by Alcon Research: epimacular membrane
• Additional relevant MeSH terms: Eye Diseases

Study Results

No Results Posted as of Mar 5, 2012