NCT00370747

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2006

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

March 15, 2013

Status Verified

March 1, 2013

Enrollment Period

9 months

First QC Date

August 30, 2006

Last Update Submit

March 13, 2013

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

  • 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

    90 days

Secondary Outcomes (1)

  • Ocular Surface Disease Index (OSDI)

    90 days

Study Arms (2)

Ecabet

EXPERIMENTAL

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

Drug: Ecabet

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

EcabetDRUG

ophthalmic solution 2.83%

Ecabet
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Have chronic systemic inflammation
  • Have active seasonal ocular allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

ecabet

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Ralph Bianca, PhD

    ISTA Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 30, 2006

First Posted

September 1, 2006

Study Start

September 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

March 15, 2013

Record last verified: 2013-03

Locations

US(1)