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NCT00333203 Clinical Trial

Next Generation Ophthalmic Irrigating Solution Posterior Segment Study

Eye Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00333203
Other study ID # C-04-18
Secondary ID
Status Completed
Phase Phase 3
First received June 1, 2006
Last updated March 1, 2012
Start date October 2005
Est. completion date March 2006

Study information
Verified date March 2012
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 369
Est. completion date March 2006
Est. primary completion date March 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Next Generation Ophthalmic Irrigating Solution (NGOIS)
Volume sufficient to irrigate adequately during cataract surgery
Other:
• BSS Plus
Volume sufficient to irrigate adequately during cataract surgery

Locations
Country Name City State
United States United States Fort Worth Texas

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Best-corrected logMAR visual acuity
Secondary Intraocular pressure (IOP)
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