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Next Generation Ophthalmic Irrigating Solution Posterior Segment Study

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.
 
ClinicalTrials.gov Identifier: NCT00333203
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : March 5, 2012
Sponsor:
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
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 : October 2005
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases
Drug Information available for: BSS plus

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




Primary Outcome Measures :
  1. Best-corrected logMAR visual acuity

Secondary Outcome Measures :
  1. Intraocular pressure (IOP)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00333203    
Other Study ID Numbers: C-04-18
First Posted: June 2, 2006    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: March 2012
Keywords provided by Alcon Research:
epimacular membrane
Additional relevant MeSH terms:
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Eye Diseases
Pharmaceutical Solutions