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Next Generation Ophthalmic Irrigating Solution Posterior Segment Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00333203
First Posted: June 2, 2006
Last Update Posted: March 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  Purpose
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
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333203


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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00333203     History of Changes
Other Study ID Numbers: C-04-18
First Submitted: June 1, 2006
First Posted: June 2, 2006
Last Update Posted: March 5, 2012
Last Verified: March 2012

Keywords provided by Alcon Research:
epimacular membrane

Additional relevant MeSH terms:
Eye Diseases
Pharmaceutical Solutions