Clinical trial NCT00784719: A Prospective, Randomized, Placebo and Active Comparator Controlled Study of CP-690,550 in Subjects With Dry Eye.
Official title: A Phase I/II Prospective, Randomized, Double Masked, Vehicle And Comparator Controlled, Dose Ranging Study Of CP-690,550 In Subjects With Dry Eye Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dry Eye Syndromes
Keywords: Dry eye
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-04
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, randomized, placebo and active comparator controlled study of CP-690,550 in subjects with dry eye.


Eligibility criteria: Inclusion Criteria:

* Symptoms of dry eye for at least 6 months.
* Signs of moderate to severe dry eye

Exclusion Criteria:

* Women who are nursing or pregnant
* Participation in other studies within 30 days of screening visit
* Ocular disorders that may confound interpretation of study results

Primary outcomes:
measure: Percentage of Participants With Systemic Adverse Events (AEs)
timeFrame: Baseline up to Week 8
measure: Percentage of Participants With Ocular Adverse Events (AEs)
timeFrame: Baseline up to Week 8
measure: Percentage of Participants With Ocular Tolerability Assessment
timeFrame: Baseline up to Week 8
measure: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia
timeFrame: Baseline through Week 8
measure: Time to Achieve 100 Percent (%) Clearance of Corneal Staining
timeFrame: Baseline through Week 8
measure: Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score
timeFrame: Baseline through Week 8
measure: Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6, 8
measure: Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8
timeFrame: Baseline, Week 8
measure: Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6
timeFrame: Week 1, 2, 4, 6
measure: Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8
timeFrame: Week 8
measure: Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6, 8
measure: Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining
timeFrame: Week 1, 2, 4, 6, 8
measure: Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6, 8
measure: Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6, 8
measure: Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6, 8
measure: Percentage of Participants With >= 5 Units Decrease in Total OCI Score
timeFrame: Week 1, 2, 4, 6, 8
measure: Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6, 8
measure: Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6, 8
measure: Percentage of Participants With >= 10 Units Decrease in Total OSDI Score
timeFrame: Week 1, 2, 4, 6, 8
measure: Change From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6, 8
measure: Change From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6, 8
measure: Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Artesia
country: United States
facility: Pfizer Investigational Site
state: California
city: Centennial
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Ormond Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Stuart
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tamarac
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Morrow
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Lynbrook
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: High Point
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Liew MS, Zhang M, Kim E, Akpek EK. Prevalence and predictors of Sjogren's syndrome in a prospective cohort of patients with aqueous-deficient dry eye. Br J Ophthalmol. 2012 Dec;96(12):1498-503. doi: 10.1136/bjophthalmol-2012-301767. Epub 2012 Sep 21.
citation: Huang JF, Yafawi R, Zhang M, McDowell M, Rittenhouse KD, Sace F, Liew SH, Cooper SR, Pickering EH. Immunomodulatory effect of the topical ophthalmic Janus kinase inhibitor tofacitinib (CP-690,550) in patients with dry eye disease. Ophthalmology. 2012 Jul;119(7):e43-50. doi: 10.1016/j.ophtha.2012.03.017. Epub 2012 May 18.
citation: Liew SH, Nichols KK, Klamerus KJ, Li JZ, Zhang M, Foulks GN. Tofacitinib (CP-690,550), a Janus kinase inhibitor for dry eye disease: results from a phase 1/2 trial. Ophthalmology. 2012 Jul;119(7):1328-35. doi: 10.1016/j.ophtha.2012.01.028. Epub 2012 Apr 22.