A Study Of Tasocitinib In Dry Eye Subjects

Pfizer

Status and phase

Withdrawn

Phase 2

Conditions

Keratoconjunctivitis Sicca

Treatments

Drug: vehicle for Tasocitinib

Drug: Tasocitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01226680

A3921066

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.