Back to resultsSafety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca
Primary Purpose
Keratoconjunctivitis Sicca
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pimecrolimus
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconjunctivitis Sicca focused on measuring KCS, dry eye, pimecrolimus, Keratoconjunctivitis sicca (dry eye syndrome)
Eligibility Criteria
Inclusion Criteria: History of artificial tear use Moderate to severe signs of dry eye Moderate to severe ocular discomfort Exclusion Criteria: 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 Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Novartis
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Pimecrolimus 0.3%
Pimecrolimus 1%
Vehicle with carbopol
Vehicle without carbopol
Arm Description
ASM981 0.3%
ASM981 1%
Outcomes
Primary Outcome Measures
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 Outcome Measures
24 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)on all signs and symptoms
Global assessment of efficacy and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00128245
Brief Title
Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca
Official Title
A 24-week Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled Evaluation of the Safety and Efficacy of 0.3% and 1% Pimecrolimus Ophthalmic Suspensions Used Twice Daily in Patients With Moderate to Severe Keratoconjunctivitis Sicca
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis Sicca
Keywords
KCS, dry eye, pimecrolimus, Keratoconjunctivitis sicca (dry eye syndrome)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
440 (false)
8. Arms, Groups, and Interventions
Arm Title
Pimecrolimus 0.3%
Arm Type
Experimental
Arm Description
ASM981 0.3%
Arm Title
Pimecrolimus 1%
Arm Type
Experimental
Arm Description
ASM981 1%
Arm Title
Vehicle with carbopol
Arm Type
Placebo Comparator
Arm Title
Vehicle without carbopol
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pimecrolimus
Other Intervention Name(s)
ASM981
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
12 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)in one sign and one symptom
Title
change from baseline in fluorescein corneal staining and ocular discomfort(worst symptom,VAS)
Secondary Outcome Measure Information:
Title
24 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)on all signs and symptoms
Title
Global assessment of efficacy and tolerability
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of artificial tear use
Moderate to severe signs of dry eye
Moderate to severe ocular discomfort
Exclusion Criteria:
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
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Foulks, Dr.
Organizational Affiliation
University of Louisville, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis
City
East Hanover
State/Province
New Jersey
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.novartisclinicaltrials.com/etrials/DiseaseID69/Dry-Eye-clinical-trials.go
Description
Novartis patient recruitment website
Learn more about this trial
Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca
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