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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ecabet

Placebo

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ecabet

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Ocular signs and Symptoms

ocular signs, including corneal and conjunctival staining, tear film breakup time and blink rate, and ocular symptoms, including burning or stinging, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness or blurriness, photophobia, photopsia, and eye discomfort

Secondary Outcome Measures

Ocular Surface Disease Index (OSDI)

Questionaire

Full Information

NCT ID

NCT00370747

First Posted

August 30, 2006

Last Updated

March 13, 2013

Sponsor

Bausch & Lomb Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT00370747

Brief Title

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

Official Title

Efficacy and Safety of Ecabet Ophthalmic Solution for the Treatment of Dry Eye Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

September 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

Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

6. Conditions and Keywords

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

Dry Eye Syndromes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

162 (false)

8. Arms, Groups, and Interventions

Arm Title

Ecabet

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ecabet

Intervention Description

ophthalmic solution 2.83%

Intervention Type

Drug

Intervention Name(s)

Ecabet

Intervention Description

ophthalmic solution 3.70%

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Ocular signs and Symptoms

Description

ocular signs, including corneal and conjunctival staining, tear film breakup time and blink rate, and ocular symptoms, including burning or stinging, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness or blurriness, photophobia, photopsia, and eye discomfort

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Ocular Surface Disease Index (OSDI)

Description

Questionaire

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ralph Bianca, PhD

Organizational Affiliation

ISTA Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

City

Irvine

State/Province

California

ZIP/Postal Code

92618

Country

United States

Dry Eye Syndromes

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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