A Study Of Tasocitinib In Dry Eye Subjects

Pfizer

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Keratoconjunctivitis Sicca

Interventions

TasocitinibDRUG

0.005% QD for 12 weeks

TasocitinibDRUG

0.003% QD for 12 weeks

vehicle for TasocitinibDRUG

vehicle QD for 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Week 12

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

Time frame: Week 12

Secondary Outcomes

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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 12 weeks

staining

Time frame: 12 weeks

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

Data from ClinicalTrials.gov

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