NCT00346528

Brief Summary

To evaluate the Safety of Next Generation Ophthalmic Irrigating Solution compared to BSS Plus for use during cataract surgery in Pediatric patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2006

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

First Submitted

Initial submission to the registry

June 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

March 5, 2012

Status Verified

March 1, 2012

Enrollment Period

11 months

First QC Date

June 28, 2006

Last Update Submit

March 1, 2012

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Safety Variables: Endothelial cell density, visual acuity, intraocular pressure, ocular signs and fundus assessment

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

Age1 Week - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Cataract present.

You may not qualify if:

  • As per age requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

glutathione-bicarbonate-Ringer solution

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Stephen Lane

    Medical Monitor

    STUDY DIRECTOR

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 28, 2006

First Posted

June 30, 2006

Study Start

July 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

March 5, 2012

Record last verified: 2012-03

Locations

US(1)