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Clinical Trials/NCT00333203
NCT00333203
Completed
Phase 3

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

Alcon Research1 site in 1 country369 target enrollmentStarted: October 2005Last updated:
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ConditionsEye Diseases
InterventionsNext Generation Ophthalmic Irrigating Solution (NGOIS)BSS Plus
DrugsNext Generation Ophthalmic Irrigating Solution (NGOIS)

Overview

Phase
Phase 3
Status
Completed
Enrollment
369
Locations
1
Primary Endpoint
Best-corrected logMAR visual acuity
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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.

Arms & Interventions

NGOIS

Experimental

Intervention: Next Generation Ophthalmic Irrigating Solution (NGOIS) (Drug)

BSS Plus

Active Comparator

Intervention: BSS Plus (Other)

Outcomes

Primary Outcomes

Best-corrected logMAR visual acuity

Secondary Outcomes

  • Intraocular pressure (IOP)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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