Next Generation Ophthalmic Irrigating Solution Posterior Segment Study

NCT ID: NCT00333203

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

369 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Eye Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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 OTHER

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 OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Under 18 years of age.
Minimum Eligible Age

18 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

Locations

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United States

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C-04-18

Identifier Type: -

Identifier Source: org_study_id

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