NCT00128245

Brief Summary

This study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%) ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (KCS, dry eye syndrome) patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
440

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2004

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

September 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

May 27, 2020

Status Verified

January 1, 2014

Enrollment Period

2.2 years

First QC Date

August 5, 2005

Last Update Submit

May 22, 2020

Conditions

Keratoconjunctivitis Sicca

Keywords

KCSdry eyepimecrolimusKeratoconjunctivitis sicca (dry eye syndrome)

Outcome Measures

Primary Outcomes (2)

  • 12 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)in one sign and one symptom

  • change from baseline in fluorescein corneal staining and ocular discomfort(worst symptom,VAS)

Secondary Outcomes (2)

  • 24 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)on all signs and symptoms

  • Global assessment of efficacy and tolerability

Study Arms (4)

Pimecrolimus 0.3%

EXPERIMENTAL

ASM981 0.3%

Drug: Pimecrolimus

Pimecrolimus 1%

EXPERIMENTAL

ASM981 1%

Drug: Pimecrolimus

Vehicle with carbopol

PLACEBO COMPARATOR
Drug: Vehicle

Vehicle without carbopol

PLACEBO COMPARATOR
Drug: Vehicle

Interventions

PimecrolimusDRUG
Also known as: ASM981
Pimecrolimus 0.3%Pimecrolimus 1%
VehicleDRUG

Placebo

Vehicle with carbopolVehicle without carbopol

Eligibility Criteria

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

You may qualify if:

  • History of artificial tear use
  • Moderate to severe signs of dry eye
  • Moderate to severe ocular discomfort

You may not qualify if:

  • Patients with uncontrolled systemic or ocular diseases.
  • Have any history of refractive surgery
  • Use any topical ocular medications other than those dispensed for the study, during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

East Hanover, New Jersey, United States

Location

Related Links

MeSH Terms

Conditions

Keratoconjunctivitis SiccaDry Eye Syndromes

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

KeratoconjunctivitisConjunctivitisConjunctival DiseasesEye DiseasesKeratitisCorneal DiseasesLacrimal Apparatus Diseases

Study Officials

  • Gary Foulks, Dr.

    University of Louisville, USA

    PRINCIPAL INVESTIGATOR

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 5, 2005

First Posted

August 9, 2005

Study Start

September 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

May 27, 2020

Record last verified: 2014-01

Locations

US(1)