A Study Of Tasocitinib In Dry Eye Subjects

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NCT01226680

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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
18-65 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 =<7 mm, sum of corneal 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.

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Keratoconjunctivitis SiccaA Study Of Tasocitinib In Dry Eye Subjects
NCT01226680
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of Tasocitinib In Dry Eye Subjects
Official Title  ICMJE A Phase II, Randomized, Double Masked, Parallel Group, Vehicle Controlled, Multiple-Dose Study Of Tasocitinib (CP-690,550) In Subjects With Dry Eye Disease
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Keratoconjunctivitis Sicca
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 27, 2018)		0
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2010)		240
Estimated Study Completion Date  ICMJE October 19, 2012
Estimated Primary Completion Date October 19, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01226680
Other Study ID Numbers  ICMJE A3921066
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP