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Safety of NGOIS Compared to BSS Plus in Pediatric Patients

Primary Purpose

Cataract

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Next Generation Ophthalmic Irrigating Solution (NGOIS)

BSS Plus

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

1 Week - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Cataract present. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: As per age requirements. Other protocol-defined exclusion criteria may apply.

Sites / Locations

Contact Alcon for Trial Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NGOIS

BSS Plus

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00346528

First Posted

June 28, 2006

Last Updated

March 1, 2012

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT00346528

Brief Title

Safety of NGOIS Compared to BSS Plus in Pediatric Patients

Official Title

Safety of NGOIS Compared to BSS Plus in Pediatric Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NGOIS

Arm Type

Experimental

Arm Title

BSS Plus

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Next Generation Ophthalmic Irrigating Solution (NGOIS)

Intervention Description

Volume sufficient to irrigate adequately during cataract surgery

Intervention Type

Drug

Intervention Name(s)

BSS Plus

Intervention Description

Volume sufficient to irrigate adequately during cataract surgery

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Week

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Cataract present. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: As per age requirements. Other protocol-defined exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen Lane

Organizational Affiliation

Medical Monitor

Official's Role

Study Director

Facility Information:

Facility Name

Contact Alcon for Trial Locations

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76134

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Safety of NGOIS Compared to BSS Plus in Pediatric Patients

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