Safety of NGOIS Compared to BSS Plus in Pediatric Patients

NCT ID: NCT00346528

Last Updated: 2012-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-06-30

Brief Summary

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

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NGOIS

Group Type EXPERIMENTAL

Next Generation Ophthalmic Irrigating Solution (NGOIS)

Intervention Type DRUG

Volume sufficient to irrigate adequately during cataract surgery

BSS Plus

Group Type ACTIVE_COMPARATOR

BSS Plus

Intervention Type DRUG

Volume sufficient to irrigate adequately during cataract surgery

Interventions

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Next Generation Ophthalmic Irrigating Solution (NGOIS)

Volume sufficient to irrigate adequately during cataract surgery

Intervention Type DRUG

BSS Plus

Volume sufficient to irrigate adequately during cataract surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Cataract present.

Exclusion Criteria

* As per age requirements.
Minimum Eligible Age

1 Week

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Lane

Role: STUDY_DIRECTOR

Medical Monitor

Locations

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Contact Alcon for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C-04-64

Identifier Type: -

Identifier Source: org_study_id

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