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Next Generation Ophthalmic Irrigating Solution Posterior Segment Study

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: June 1, 2006
Last updated: March 1, 2012
Last verified: March 2012
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 Intervention Phase
Eye Diseases
Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS)
Other: BSS Plus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Best-corrected logMAR visual acuity

Secondary Outcome Measures:
  • Intraocular pressure (IOP)

Enrollment: 369
Study Start Date: October 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00333203

United States, Texas
United States
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Alcon Research Identifier: NCT00333203     History of Changes
Other Study ID Numbers: C-04-18
Study First Received: June 1, 2006
Last Updated: March 1, 2012

Keywords provided by Alcon Research:
epimacular membrane

Additional relevant MeSH terms:
Eye Diseases
Pharmaceutical Solutions processed this record on May 25, 2017