NCT00333268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
369

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
Last Updated

March 5, 2012

Status Verified

March 1, 2012

Enrollment Period

10 months

First QC Date

June 1, 2006

Last Update Submit

March 1, 2012

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Percent change in endothelial cell density

Secondary Outcomes (1)

  • Best corrected logMAR visual acuity

Study Arms (2)

NGOIS

EXPERIMENTAL
Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS)

BSS Plus

ACTIVE COMPARATOR
Drug: BSS Plus

Interventions

Next Generation Ophthalmic Irrigating Solution (NGOIS)DRUG

Volume sufficient to irrigate adequately during cataract surgery

NGOIS
BSS PlusDRUG

Volume sufficient to irrigate adequately during cataract surgery

BSS Plus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients any race or sex 18 or older and undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens.

You may not qualify if:

  • Under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United States

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

glutathione-bicarbonate-Ringer solution

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2006

First Posted

June 2, 2006

Study Start

September 1, 2004

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

March 5, 2012

Record last verified: 2012-03

Locations

US(1)