A Study Of Tasocitinib In Dry Eye Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-01

Study Completion Date

2012-10-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Keratoconjunctivitis Sicca

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Tasocitinib 0.005% QD

Group Type EXPERIMENTAL

Tasocitinib

Intervention Type DRUG

0.005% QD for 12 weeks

Tasocitinib 0.003% QD

Group Type EXPERIMENTAL

Tasocitinib

Intervention Type DRUG

0.003% QD for 12 weeks

Vehicle for Tasocitinib

Group Type PLACEBO_COMPARATOR

vehicle for Tasocitinib

Intervention Type DRUG

vehicle QD for 12 weeks

Interventions

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Tasocitinib

0.005% QD for 12 weeks

Intervention Type DRUG

Tasocitinib

0.003% QD for 12 weeks

Intervention Type DRUG

vehicle for Tasocitinib

vehicle QD for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No