CClinicalTrials.gg
CompletedNCT00333203Updated Mar 5, 2012

Next Generation Ophthalmic Irrigating Solution Posterior Segment Study

A Phase 3 interventional study of Next Generation Ophthalmic Irrigating Solution (NGOIS) and BSS Plus in Eye Diseases, sponsored by Alcon Research. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-05.

Sponsored by Alcon Research · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
369
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Eye Diseases

Browse trials for

Keywords

  • epimacular membrane
03

In context

Eye Diseases

740 studies on the registry are indexed under Eye Diseases; 117 are open to participants now.

This study's enrollment of 369 is above the median of 68 across 547 interventional studies indexed under Eye Diseases.

Browse Eye Diseases studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Under 18 years of age.
  • Other protocol-defined exclusion criteria may apply.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
369 participants (actual)

Study arms

  • Experimental
    NGOIS

    Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS)

  • Active comparator
    BSS Plus

    Other: BSS Plus

Interventions

  • DrugNext Generation Ophthalmic Irrigating Solution (NGOIS)

    Volume sufficient to irrigate adequately during cataract surgery

  • OtherBSS Plus

    Volume sufficient to irrigate adequately during cataract surgery

06

What researchers measure

Primary outcomes

  1. Best-corrected logMAR visual acuity

Secondary outcomes

  1. Intraocular pressure (IOP)

07

Study locations

1 site
  • United States
    Fort Worth, Texas 76134, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00333203
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Jun 2, 2006
Start date
Oct 2005
Primary completion
Mar 2006
Completion
Mar 2006
Last update
Mar 5, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion