Keratoconjunctivitis Sicca
Conditions
Keywords
Dry Eye, Schirmer test, corneal staining, OSDI, OCI
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.
Interventions
DRUGTasocitinib
0.005% QD for 12 weeks
DRUGvehicle for Tasocitinib
vehicle QD for 12 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Systemic safety: adverse events, clinical laboratory; and vital signs | 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 | 12 weeks |
| 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 |
| ≥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 |
| staining | 12 weeks |
| 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 |
Outcome results
None listed