Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome

NCT ID: NCT00370747

Last Updated: 2013-03-15

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

PHASE2

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-06-30

Brief Summary

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The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome

Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Ecabet

Ophthalmic solution in the Study eye four times daily for 90 days.

Group Type EXPERIMENTAL

Ecabet

Intervention Type DRUG

ophthalmic solution 2.83%

Ecabet

Intervention Type DRUG

ophthalmic solution 3.70%

Placebo

Ophthalmic solution in the Study eye four times daily for 90 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Ecabet

ophthalmic solution 2.83%

Intervention Type DRUG

Ecabet

ophthalmic solution 3.70%

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male/female at least 18 years of age
* Agree to avoid disallowed medications
* Have a diagnosis of dry eye

Exclusion Criteria

* Have chronic systemic inflammation
* Have active seasonal ocular allergies
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ralph Bianca, PhD

Role: STUDY_DIRECTOR

ISTA Pharmaceuticals, Inc.

Locations

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Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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ISTA-ECBT-CS02

Identifier Type: -

Identifier Source: org_study_id

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