NCT00333203

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.

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 Oct 2005

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

October 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
3 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

5 months

First QC Date

June 1, 2006

Last Update Submit

March 1, 2012

Conditions

Eye Diseases

Keywords

epimacular membrane

Outcome Measures

Primary Outcomes (1)

  • Best-corrected logMAR visual acuity

Secondary Outcomes (1)

  • Intraocular pressure (IOP)

Study Arms (2)

NGOIS

EXPERIMENTAL
Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS)

BSS Plus

ACTIVE COMPARATOR
Other: BSS Plus

Interventions

Next Generation Ophthalmic Irrigating Solution (NGOIS)DRUG

Volume sufficient to irrigate adequately during cataract surgery

NGOIS
BSS PlusOTHER

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 of any race and sex, with an epimacular membrane who would benefit from vitrectomy and membrane removal.

You may not qualify if:

  • Under 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United States

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Eye DiseasesEpiretinal Membrane

Interventions

glutathione-bicarbonate-Ringer solution

Condition Hierarchy (Ancestors)

Retinal Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
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

October 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

March 5, 2012

Record last verified: 2012-03

Locations

US(1)