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Next Generation Ophthalmic Irrigating Solution Posterior Segment Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00333203
First received: June 1, 2006
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  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
Endpoint Classification: Safety Study
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:

MedlinePlus related topics: Eye Diseases
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333203

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00333203     History of Changes
Other Study ID Numbers: C-04-18
Study First Received: June 1, 2006
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
epimacular membrane

Additional relevant MeSH terms:
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013