A Study Of Tasocitinib In Dry Eye Subjects - Full Text View

Purpose

This is a phase 2 study to further evaluate the safety and efficacy of tasocitinib (CP-690,550) in the subjects with moderate to severe dry eye disease. Both subjective and objective clinical endpoints will be measured for a duration of 12-week treatment.

Condition	Intervention	Phase
Keratoconjunctivitis Sicca	Drug: Tasocitinib Drug: vehicle for Tasocitinib	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase II, Randomized, Double Masked, Parallel Group, Vehicle Controlled, Multiple-Dose Study Of Tasocitinib (CP-690,550) In Subjects With Dry Eye Disease

Resource links provided by NLM:

Genetics Home Reference related topics: keratitis-ichthyosis-deafness syndrome

MedlinePlus related topics: Eye Diseases

Drug Information available for: Tofacitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change in length of wetting of Schirmer test strip without anesthesia from baseline [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Change in Ocular Surface Disease Index's Environmental Trigger (OSDI-ET) subscale score from baseline [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Systemic safety: adverse events, clinical laboratory; and vital signs [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Ocular tolerability and safety: incidence and severity of ocular adverse events during the study (ophthalmic examination, ocular tolerability assessment and/ or adverse events spontaneously reported) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Schirmer test without anesthesia: Change in length of wetting from baseline at Days 7, 14, 28, and Week 8; Response rate (percentage of subjects who achieve ≥10mm wetting) at Days 7, 14, 28, and Weeks 8 and 12; Response rate (percentage of [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
subjects who achieve increase of ≥10mm wetting) at Days 7, 14, 28, and Weeks 8 and 12; Time to achievement of change from baseline of ≥10mm wetting;Time to achievement of ≥10mm wetting [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Corneal staining:Change from baseline at Days 7, 14, 28 and Weeks 8 and 12;Response rate (percentage of subjects who demonstrate 100% clearing of corneal staining) at Days 7, 14, 28 and Weeks 8 and 12;Time to achievement of 100% clearing of corneal [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
staining [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Ocular Surface Disease Index (OSDI): Change in the OSDI total score and three subscale scores (the Ocular Symptoms, Vision-Related Function, and Environmental Triggers) from baseline at Days 7, 14, 28, and Weeks 8 and 12 (except ET subscale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
score); Response rate (percentage of subjects who demonstrating ≥10 unit decrease in OSDI total score) at Days 7, 14, 28, and Weeks 8 and 12; Time to achievement of ≥10 unit decrease in OSDI total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Modified Ocular Comfort Index (mOCI): Change in the OCI score, the Dry Eye Symptoms (DES) and Symptom Interference (SI) subscales scores from baseline at Days 7, 14, 28 and Weeks 8 and 12; OCI Response rate (percentage of subjects who demonstrating [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
≥3 point decrease from baseline in the OCI score) at Days 7, 14, 28, and Weeks 8 and 12; Time to achievement of ≥3 point decrease from baseline in the OCI score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	December 2010
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Tasocitinib 0.005% QD	Drug: Tasocitinib 0.005% QD for 12 weeks
Experimental: Tasocitinib 0.003% QD	Drug: Tasocitinib 0.003% QD for 12 weeks
Placebo Comparator: Vehicle for Tasocitinib	Drug: vehicle for Tasocitinib vehicle QD for 12 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females aged 18 years or older at time of consent
Diagnosis of dry eye disease, characterized by subjective symptoms of dry eye for at least 6 months, Schirmer test without anesthesia: =>1 mm and =<7 mm, sum of corneal fluorescein staining score of =>4 (NEI Scale), and subject grading total score of => 23 on the OSDI

Exclusion Criteria:

Planned initiation of, or changes to, concomitant medication that could affect dry eye within 30 days of the Screening visit or during study
Ocular disorders that may confound interpretation of study results such as significant corneal surface disease not caused by dry eyes, abnormal corneal sensitivity, abnormal tear spreading, including but not limited to the following: abnormal lid function, lid position, or blink rate, that in the opinion of the investigator is clinically significant, history of herpetic keratopathy
Lacrimal punctal occlusion (plugs or cautery) within 2 months of the Screening visit
Contact lens wear within 2 weeks of the Screening visit and/or during study participation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226680

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT01226680 History of Changes
Other Study ID Numbers:	A3921066
Study First Received:	October 20, 2010
Last Updated:	December 21, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Dry Eye
Schirmer test
corneal staining
OSDI
OCI

Additional relevant MeSH terms:

Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases

Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on May 23, 2013