A Study Of Tasocitinib In Dry Eye Subjects

Keratoconjunctivitis Sicca Clinical Trial

Official title:

A Phase II, Randomized, Double Masked, Parallel Group, Vehicle Controlled, Multiple-Dose Study Of Tasocitinib (CP-690,550) In Subjects With Dry Eye Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01226680
• Other study ID #: A3921066
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 1, 2010
• Est. completion date: October 19, 2012

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 19, 2012
• Est. primary completion date: October 19, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Tasocitinib
0.005% QD for 12 weeks
• Tasocitinib
0.003% QD for 12 weeks
• vehicle for Tasocitinib
vehicle QD for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in length of wetting of Schirmer test strip without anesthesia from baseline		Week 12
Primary	Change in Ocular Surface Disease Index's Environmental Trigger (OSDI-ET) subscale score from baseline		Week 12
Secondary	Systemic safety: adverse events, clinical laboratory; and vital signs		12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	staining		12 weeks
Secondary	Ocular Surface Disease Index (OSDI): Change in the OSDI total score and three subscale scores (the Ocular Symptoms, Vision-Related Function, and Environmental Triggers) from baseline at Days 7, 14, 28, and Weeks 8 and 12 (except ET subscale		12 weeks
Secondary	score); Response rate (percentage of subjects who demonstrating =10 unit decrease in OSDI total score) at Days 7, 14, 28, and Weeks 8 and 12; Time to achievement of =10 unit decrease in OSDI total score		12 weeks
Secondary	Modified Ocular Comfort Index (mOCI): Change in the OCI score, the Dry Eye Symptoms (DES) and Symptom Interference (SI) subscales scores from baseline at Days 7, 14, 28 and Weeks 8 and 12; OCI Response rate (percentage of subjects who demonstrating		12 weeks
Secondary	=3 point decrease from baseline in the OCI score) at Days 7, 14, 28, and Weeks 8 and 12; Time to achievement of =3 point decrease from baseline in the OCI score		12 weeks

External Links

•   To obtain contact information for a study center near you, click here.