A Prospective, Randomized, Placebo and Active Comparator Controlled Study of CP-690,550 in Subjects With Dry Eye.
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.
1 other identifier
interventional
327
1 country
27
Brief Summary
A prospective, randomized, placebo and active comparator controlled study of CP-690,550 in subjects with dry eye.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2008
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 3, 2008
CompletedFirst Posted
Study publicly available on registry
November 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
April 9, 2013
CompletedApril 9, 2013
February 1, 2013
11 months
November 3, 2008
November 29, 2012
February 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percentage of Participants With Systemic Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation.
Baseline up to Week 8
Percentage of Participants With Ocular Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Ocular AEs are the events which are localized in the ocular region.
Baseline up to Week 8
Percentage of Participants With Ocular Tolerability Assessment
Ocular tolerability assessment included evaluation of severity and duration of the 5 symptoms: burning/stinging, blurred vision, ocular discomfort, pain, tearing. Severity was assessed on a 4-point scale, where 0=none, 1=mild, 2=moderate and 3=severe. Duration was assessed as immediate (if subsided within 5 minutes \[\<5 min\] after application) or persistent (if continued beyond 5 minutes \[\>=5 min\] after application).
Baseline up to Week 8
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 millimeter (mm). If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Week 8
Secondary Outcomes (19)
Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia
Baseline through Week 8
Time to Achieve 100 Percent (%) Clearance of Corneal Staining
Baseline through Week 8
Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score
Baseline through Week 8
Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8
Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8
Baseline, Week 8
- +14 more secondary outcomes
Study Arms (6)
Treatment 1
EXPERIMENTALTreatment 2
EXPERIMENTALTreatment 3
EXPERIMENTALTreatment 4
EXPERIMENTALActive comparator
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Ophthalmic topical solution, 0.05%, dosed at least once/day, 8 weeks
Eligibility Criteria
You may qualify if:
- Symptoms of dry eye for at least 6 months.
- Signs of moderate to severe dry eye
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (27)
Pfizer Investigational Site
Chandler, Arizona, 85286, United States
Pfizer Investigational Site
Peoria, Arizona, 85381, United States
Pfizer Investigational Site
Phoenix, Arizona, 85032, United States
Pfizer Investigational Site
Artesia, California, 90701, United States
Pfizer Investigational Site
Centennial, Colorado, 80112, United States
Pfizer Investigational Site
Ormond Beach, Florida, 32174, United States
Pfizer Investigational Site
Stuart, Florida, 34994, United States
Pfizer Investigational Site
Tamarac, Florida, 33321, United States
Pfizer Investigational Site
Tampa, Florida, 33603, United States
Pfizer Investigational Site
Atlanta, Georgia, 30342, United States
Pfizer Investigational Site
Morrow, Georgia, 30260, United States
Pfizer Investigational Site
Roswell, Georgia, 30076, United States
Pfizer Investigational Site
Louisville, Kentucky, 40217, United States
Pfizer Investigational Site
Baltimore, Maryland, 21287, United States
Pfizer Investigational Site
Boston, Massachusetts, 02114, United States
Pfizer Investigational Site
Kansas City, Missouri, 64111, United States
Pfizer Investigational Site
Lynbrook, New York, 11563, United States
Pfizer Investigational Site
Rochester, New York, 14618, United States
Pfizer Investigational Site
Charlotte, North Carolina, 28210, United States
Pfizer Investigational Site
High Point, North Carolina, 27262, United States
Pfizer Investigational Site
Cleveland, Ohio, 44115, United States
Pfizer Investigational Site
Columbus, Ohio, 43210, United States
Pfizer Investigational Site
Memphis, Tennessee, 38119, United States
Pfizer Investigational Site
Austin, Texas, 78705, United States
Pfizer Investigational Site
Austin, Texas, 78731, United States
Pfizer Investigational Site
Austin, Texas, 78746, United States
Pfizer Investigational Site
San Antonio, Texas, 78240, United States
Related Publications (3)
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.
PMID: 23001257DERIVEDHuang 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.
PMID: 22607938DERIVEDLiew 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.
PMID: 22525048DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
In this study, a variance was made in the planned analysis. At the time of data analysis, results from Stage 1 and 2 were combined for efficacy and safety analyses. Hence, results are presented together for both stages.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2008
First Posted
November 4, 2008
Study Start
November 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
April 9, 2013
Results First Posted
April 9, 2013
Record last verified: 2013-02