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Clinical Trials/NCT00333268
NCT00333268
Completed
Phase 3

Clinical Evaluation of the Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus for Use During Cataract Extraction and IOL Implantation

Alcon Research1 site in 1 country369 target enrollmentStarted: September 2004Last updated:
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ConditionsCataract
InterventionsNext Generation Ophthalmic Irrigating Solution (NGOIS)BSS Plus
DrugsNext Generation Ophthalmic Irrigating Solution (NGOIS)BSS Plus

Overview

Phase
Phase 3
Status
Completed
Enrollment
369
Locations
1
Primary Endpoint
Percent change in endothelial cell density
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The purpose of this study is to determine the safety and efficacy of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS Plus for use during cataract extraction and intra-ocular lens (IOL) implantation.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients any race or sex 18 or older and undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens.
  • •Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

  • •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 (Drug)

Outcomes

Primary Outcomes

Percent change in endothelial cell density

Secondary Outcomes

  • Best corrected logMAR visual acuity

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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