NCT00667004

Brief Summary

Efficacy study of ecabet ophthalmic solution in dry eye disease

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2008

Completed
12 years until next milestone

Results Posted

Study results publicly available

September 3, 2020

Completed
Last Updated

September 3, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

April 23, 2008

Results QC Date

August 18, 2020

Last Update Submit

August 18, 2020

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline in Lacrimation Assessed by Schirmer's Test

    The Schirmer's test is used determine if tear glands produce enough tears to keep eyes adequately moist. Calibrated strips of a non-toxic filter paper are used. One free end is placed within the lower eyelid. At the conclusion of the test, the paper strip is removed from the lower eyelid and the amount of wetting of the paper strip is measured.

    43 days

Study Arms (2)

1

EXPERIMENTAL

ecabet ophthalmic solution

Drug: ecabet ophthalmic solution

2

PLACEBO COMPARATOR

Placebo comparator

Drug: placebo

Interventions

ecabet ophthalmic solutionDRUG

sterile ophthalmic solution

1
placeboDRUG

sterile ophthalmic solution

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with dry eye disease

You may not qualify if:

  • Dry eye disease secondary to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISTA Pharmaceuticals, Inc.

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Study Director
Organization
Bausch Health
susan.harris@bauschhealth.com

Study Officials

  • Tim McNamara, PharmD

    ISTA Pharmaceuticals, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 25, 2008

Study Start

March 22, 2008

Primary Completion

September 12, 2008

Study Completion

September 12, 2008

Last Updated

September 3, 2020

Results First Posted

September 3, 2020

Record last verified: 2020-08

Locations

US(1)