Dry Eye SyndromesPhase 1/2NCT00784719

A Prospective, Randomized, Placebo and Active Comparator Controlled Study of CP-690,550 in Subjects With Dry Eye.

A Phase 1/2 study testing CP-690,550 and Cyclosporine in people with Dry Eye Syndromes, run by Pfizer at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A prospective, randomized, placebo and active comparator controlled study of CP-690,550 in subjects with dry eye. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndromes
What is being tested?: CP-690,550 and Cyclosporine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 327 participants
Where: 27 sitesUnited States
Study dates: Nov 2008to Oct 2009
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Pfizer Investigational Site
Artesia, California, 90701
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Austin, Texas, 78731
Pfizer Investigational Site
Austin, Texas, 78746
Pfizer Investigational Site
Baltimore, Maryland, 21287
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Centennial, Colorado, 80112
Pfizer Investigational Site
Chandler, Arizona, 85286
Pfizer Investigational Site
Charlotte, North Carolina, 28210
Pfizer Investigational Site
Cleveland, Ohio, 44115
Pfizer Investigational Site
Columbus, Ohio, 43210
Pfizer Investigational Site
High Point, North Carolina, 27262
Pfizer Investigational Site
Kansas City, Missouri, 64111
Pfizer Investigational Site
Louisville, Kentucky, 40217
Pfizer Investigational Site
Lynbrook, New York, 11563
Pfizer Investigational Site
Memphis, Tennessee, 38119
Pfizer Investigational Site
Morrow, Georgia, 30260
Pfizer Investigational Site
Ormond Beach, Florida, 32174
Pfizer Investigational Site
Peoria, Arizona, 85381
Pfizer Investigational Site
Phoenix, Arizona, 85032
Pfizer Investigational Site
Rochester, New York, 14618
Pfizer Investigational Site
Roswell, Georgia, 30076
Pfizer Investigational Site
San Antonio, Texas, 78240
Pfizer Investigational Site
Stuart, Florida, 34994
Pfizer Investigational Site
Tamarac, Florida, 33321
Pfizer Investigational Site
Tampa, Florida, 33603

Other trials in United States

About this study

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.

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

Conditions: Dry Eye Syndromes
Being tested: CP-690,550, Cyclosporine, CP-690,550 Vehicle
Keywords: Dry eye
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CP-690,550Drug
Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks
CP-690,550Drug
Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks
CP-690,550Drug
Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks
CP-690,550Drug
Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks
CyclosporineDrug
Ophthalmic topical solution, 0.05%, dosed at least once/day, 8 weeks
CP-690,550 VehicleDrug
Ophthalmic topical solution, dosed at least once/day, 8 weeks

Study groups in NCT00784719
Study group	Role	What they receive
Treatment 1	Experimental	Not described Receives: Drug: CP-690,550
Treatment 2	Experimental	Not described Receives: Drug: CP-690,550
Treatment 3	Experimental	Not described Receives: Drug: CP-690,550
Treatment 4	Experimental	Not described Receives: Drug: CP-690,550
Active comparator	Active comparator	Not described Receives: Drug: Cyclosporine
Placebo	Placebo comparator	Not described Receives: Drug: CP-690,550 Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Week 8

Secondary outcomes (19)

Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia
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 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.
Measured: Baseline through Week 8
Time to Achieve 100 Percent (%) Clearance of Corneal Staining
Corneal staining was assessed by instilling sodium fluorescein dye in the eye and after 1 to 2 minutes, observing for corneal staining with the aid of a yellow filter and slit lamp. The cornea was divided into five different zones and each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Results from study eye were to be reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Measured: Baseline through Week 8
Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score
OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contained 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.
Measured: Baseline through Week 8
Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 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 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.
Measured: Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8
Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was 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 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.
Measured: Baseline, Week 8
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6
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 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.
Measured: Week 1, 2, 4, 6
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8
Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was 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 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.
Measured: Week 8
Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8
Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. 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.
Measured: Baseline, Week 1, 2, 4, 6, 8
Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining
Corneal staining was assessed using fluorescein dye, yellow filter, slit lamp. Cornea was divided into 5 different zones. Each corneal zone was graded independently using 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. 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.
Measured: Week 1, 2, 4, 6, 8
Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8
Interpalpebral conjunctival staining was performed 1 minute following ocular administration of lissamine green dye with aid of slit lamp. Based on Oxford grading system, bulbar conjunctiva was divided into 2 zones: nasal, temporal. Staining were graded using a 6-point scale (0=absent, 5=severe). Total score=sum of 2 zone scores. Total score range: 0 to 10, higher score=higher damage to eyes due to dryness. Negative change from baseline indicated improvement. Results from study eye are reported. Study eye is the eye with worse Schirmer test score without anesthesia score at baseline.
Measured: Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8
TBUT was the time interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. It was measured under a slit lamp following instillation of fluorescein dye in the eye using a stopwatch. 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.
Measured: Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8
OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.
Measured: Baseline, Week 1, 2, 4, 6, 8
Percentage of Participants With >= 5 Units Decrease in Total OCI Score
OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort.
Measured: Week 1, 2, 4, 6, 8
Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8
Daily artificial tear use was assessed by collecting data on daily number of drops of artificial tear instilled in the eye using a participant diary. Decrease in daily artificial tear use indicated improvement.
Measured: Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
OSDI is a validated instrument for ocular surface disease. It has 12 items, each measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score (question 1 [Q1]-Q12) and three subscale scores can be derived: Ocular Symptom (Q1-Q3), Vision-related function (Q4-Q9), and Environmental trigger (Q10-Q12). Each derived score ranges from 0 to 100, with a higher score indicates worse condition.
Measured: Baseline, Week 1, 2, 4, 6, 8
Percentage of Participants With >= 10 Units Decrease in Total OSDI Score
OSDI is a validated instrument for ocular surface disease. It has 12 items, each has a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score can be derived which ranges from 0 to 100; a higher score indicates worse ocular disease.
Measured: Week 1, 2, 4, 6, 8
Change From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8
OSDI is a validated instrument for ocular surface disease. It has 12 items, each with a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time).
Measured: Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8
mOCI consisted of the original 12-item OCI plus additional questions on other dry eye symptoms and their impact to participant's life. Each item was measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Negative change from baseline indicated improvement.
Measured: Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: general health (GH), general vision (GV), ocular pain (OP), near activities (NAct), distance activities (DA), social functioning (SF), mental health (MH), role difficulties (RD), dependency, driving, color vision (CV) and peripheral vision (PV). Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score=less symptoms/better visual functioning.
Measured: Baseline, Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Oct 2009

First posted4 Nov 2008 (estimated)
Study startNov 2008
Primary completionOct 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 327 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00784719
Sponsor's protocol ID: A3921034
Other IDs: A3921034
Status last verified: Feb 2013
First submitted: 3 Nov 2008
Last updated: 9 Apr 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 23001257
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.
PubMed 22607938
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.
PubMed 22525048

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00784719
Acronym / sponsor ID: A3921034
Conditions: Dry Eye Syndromes
Keywords: Dry eye
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 327 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 4 Nov 2008 (estimated)
Results: Posted 9 Apr 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Treatment 1	Experimental	Drug: CP-690,550
Treatment 2	Experimental	Drug: CP-690,550
Treatment 3	Experimental	Drug: CP-690,550
Treatment 4	Experimental	Drug: CP-690,550
Active comparator	Active comparator	Drug: Cyclosporine
Placebo	Placebo comparator	Drug: CP-690,550 Vehicle

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CP-690,550Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks	Drug	Treatment 1
CP-690,550Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks	Drug	Treatment 2
CP-690,550Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks	Drug	Treatment 3
CP-690,550Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks	Drug	Treatment 4
CyclosporineOphthalmic topical solution, 0.05%, dosed at least once/day, 8 weeks	Drug	Active comparator
CP-690,550 VehicleOphthalmic topical solution, dosed at least once/day, 8 weeks	Drug	Placebo

Primary outcome

Percentage of Participants With Systemic Adverse Events (AEs)
Time frame: Baseline up to Week 8
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.
Percentage of Participants With Ocular Adverse Events (AEs)
Time frame: Baseline up to Week 8
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.
Percentage of Participants With Ocular Tolerability Assessment
Time frame: Baseline up to Week 8
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).
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8
Time frame: 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.

19 secondary outcomes

Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia
Time frame: Baseline through Week 8
Time to Achieve 100 Percent (%) Clearance of Corneal Staining
Time frame: Baseline through Week 8
Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score
Time frame: Baseline through Week 8
Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8
Time frame: Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8
Time frame: Baseline, Week 8
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6
Time frame: Week 1, 2, 4, 6
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8
Time frame: Week 8
Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8
Time frame: Baseline, Week 1, 2, 4, 6, 8
Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining
Time frame: Week 1, 2, 4, 6, 8
Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8
Time frame: Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8
Time frame: Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8
Time frame: Baseline, Week 1, 2, 4, 6, 8
Percentage of Participants With >= 5 Units Decrease in Total OCI Score
Time frame: Week 1, 2, 4, 6, 8
Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8
Time frame: Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Time frame: Baseline, Week 1, 2, 4, 6, 8
Percentage of Participants With >= 10 Units Decrease in Total OSDI Score
Time frame: Week 1, 2, 4, 6, 8
Change From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8
Time frame: Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8
Time frame: Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Time frame: Baseline, Week 8

Results and safety

Results posted to the registry on 9 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Twice Daily	47	44
CP-690,550, 0.0003% Twice Daily	46	43
CP-690,550, 0.001% Twice Daily	47	46
CP-690,550, 0.003% Twice Daily	48	48
CP-690,550, 0.005% Twice Daily	48	42
CP-690,550, 0.005% Once Daily	44	41
Restasis Twice Daily	47	42

Primary outcome: Percentage of Participants With Systemic Adverse Events (AEs)

Time frame: Baseline up to Week 8. Number. Unit: percentage of participants

Measure	Placebo Twice Daily n = 47	CP-690,550, 0.0003% Twice Daily n = 46	CP-690,550, 0.001% Twice Daily n = 47	CP-690,550, 0.003% Twice Daily n = 48	CP-690,550, 0.005% Twice Daily n = 48	CP-690,550, 0.005% Once Daily n = 44	Restasis Twice Daily n = 47
Value	27.7	8.7	29.8	27.1	18.8	18.2	23.4

Population analysed: Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study medication.

Primary outcome: Percentage of Participants With Ocular Adverse Events (AEs)

Time frame: Baseline up to Week 8. Number. Unit: percentage of participants

Measure	Placebo Twice Daily n = 47	CP-690,550, 0.0003% Twice Daily n = 46	CP-690,550, 0.001% Twice Daily n = 47	CP-690,550, 0.003% Twice Daily n = 48	CP-690,550, 0.005% Twice Daily n = 48	CP-690,550, 0.005% Once Daily n = 44	Restasis Twice Daily n = 47
Value	25.5	21.7	31.9	22.9	22.9	22.7	36.2

Population analysed: ITT population included all enrolled participants who received at least 1 dose of study medication.

Primary outcome: Percentage of Participants With Ocular Tolerability Assessment

Time frame: Baseline up to Week 8. Number. Unit: percentage of participants

Measure	Placebo Twice Daily n = 45	CP-690,550, 0.0003% Twice Daily n = 46	CP-690,550, 0.001% Twice Daily n = 47	CP-690,550, 0.003% Twice Daily n = 48	CP-690,550, 0.005% Twice Daily n = 47	CP-690,550, 0.005% Once Daily n = 43	Restasis Twice Daily n = 44
Ocular discomfort:none	55.6	50.0	53.2	52.1	46.8	69.8	34.1
Ocular discomfort:mild	33.3	28.3	25.5	29.2	44.7	18.6	34.1
Ocular discomfort:moderate	11.1	19.6	19.1	14.6	8.5	9.3	25.0
Ocular discomfort:severe	0.0	2.2	2.1	4.2	0.0	2.3	6.8
Ocular discomfort:moderate/severe, duration>=5 min	4.4	10.9	8.5	10.4	4.3	7.0	22.7
Burning sensation:none	26.7	43.5	23.4	33.3	29.8	32.6	18.2
Burning sensation:mild	55.6	39.1	59.6	39.6	53.2	48.8	40.9
Burning sensation:moderate	17.8	15.2	14.9	22.9	14.9	16.3	36.4

Population analysed: ITT population included all enrolled participants who received at least one dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Primary outcome: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8

Time frame: Week 8. Number. Unit: percentage of participants

Measure	Placebo Twice Daily n = 45	CP-690,550, 0.0003% Twice Daily n = 45	CP-690,550, 0.001% Twice Daily n = 47	CP-690,550, 0.003% Twice Daily n = 48	CP-690,550, 0.005% Twice Daily n = 46	CP-690,550, 0.005% Once Daily n = 44	Restasis Twice Daily n = 45
Value	20.0	17.8	25.5	18.8	26.1	27.3	35.6

Population analysed: ITT population included all enrolled participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) was the method used for imputing missing data at Week 8.

19 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Twice Daily	0 of 47 (0%)	23 of 47 (48.9%)	Not reported
CP-690,550, 0.0003% Twice Daily	1 of 46 (2.2%)	11 of 46 (23.9%)	Not reported
CP-690,550, 0.001% Twice Daily	0 of 47 (0%)	22 of 47 (46.8%)	Not reported
CP-690,550, 0.003% Twice Daily	1 of 48 (2.1%)	21 of 48 (43.8%)	Not reported
CP-690,550, 0.005% Twice Daily	1 of 48 (2.1%)	15 of 48 (31.3%)	Not reported
CP-690,550, 0.005% Once Daily	1 of 44 (2.3%)	15 of 44 (34.1%)	Not reported
Restasis Twice Daily	1 of 47 (2.1%)	26 of 47 (55.3%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23001257Liew 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.
Derived from this study: PubMed 22607938Huang 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.
Derived from this study: PubMed 22525048Liew 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CP-690,550 and Cyclosporine in people with Dry Eye Syndromes, run by Pfizer at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Systemic Adverse Events (AEs) (time frame: Baseline up to Week 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00784719, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2013.