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A Study Of Tasocitinib In Dry Eye Subjects

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Keratoconjunctivitis Sicca
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 = fluorescein staining score of =>4 (NEI Scale), and subject grading total score of =>
23 on the OSDI

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01226680
Pfizer
Withdrawn
A Study Of Tasocitinib In Dry Eye Subjects

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Keratoconjunctivitis Sicca
NCT01226680
All Genders
A Study Of Tasocitinib In Dry Eye Subjects
A Phase II, Randomized, Double Masked, Parallel Group, Vehicle Controlled, Multiple-Dose Study Of Tasocitinib (CP-690,550) In Subjects With Dry Eye Disease
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Keratoconjunctivitis Sicca
  • Drug: Tasocitinib
    0.005% QD for 12 weeks
  • Drug: Tasocitinib
    0.003% QD for 12 weeks
  • Drug: vehicle for Tasocitinib
    vehicle QD for 12 weeks
  • Experimental: Tasocitinib 0.005% QD
    Intervention: Drug: Tasocitinib
  • Experimental: Tasocitinib 0.003% QD
    Intervention: Drug: Tasocitinib
  • Placebo Comparator: Vehicle for Tasocitinib
    Intervention: Drug: vehicle for Tasocitinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
240
November 2011
October 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01226680
A3921066
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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