NCT01226680

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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2010

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2012

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

1.9 years

First QC Date

October 20, 2010

Last Update Submit

November 27, 2018

Conditions

Keratoconjunctivitis Sicca

Keywords

Dry EyeSchirmer testcorneal stainingOSDIOCI

Outcome Measures

Primary Outcomes (2)

  • Change in length of wetting of Schirmer test strip without anesthesia from baseline

    Week 12

  • Change in Ocular Surface Disease Index's Environmental Trigger (OSDI-ET) subscale score from baseline

    Week 12

Secondary Outcomes (10)

  • Systemic safety: adverse events, clinical laboratory; and vital signs

    12 weeks

  • 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)

    12 weeks

  • 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

    12 weeks

  • 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

    12 weeks

  • 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

    12 weeks

  • +5 more secondary outcomes

Study Arms (3)

Tasocitinib 0.005% QD

EXPERIMENTAL
Drug: Tasocitinib

Tasocitinib 0.003% QD

EXPERIMENTAL
Drug: Tasocitinib

Vehicle for Tasocitinib

PLACEBO COMPARATOR
Drug: vehicle for Tasocitinib

Interventions

TasocitinibDRUG

0.005% QD for 12 weeks

Tasocitinib 0.005% QD
vehicle for TasocitinibDRUG

vehicle QD for 12 weeks

Vehicle for Tasocitinib

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Keratoconjunctivitis SiccaDry Eye Syndromes

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

KeratoconjunctivitisConjunctivitisConjunctival DiseasesEye DiseasesKeratitisCorneal DiseasesLacrimal Apparatus Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2010

First Posted

October 22, 2010

Study Start

December 1, 2010

Primary Completion

October 19, 2012

Study Completion

October 19, 2012

Last Updated

November 29, 2018

Record last verified: 2018-11