Keratoconjunctivitis SiccaPhase 2NCT01226680
A Study Of Tasocitinib In Dry Eye Subjects
A Phase 2 study testing Tasocitinib in people with Keratoconjunctivitis Sicca, run by Pfizer.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Keratoconjunctivitis Sicca
- What is being tested?
- Tasocitinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2010to 19 Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: A Phase II, Randomized, Double Masked, Parallel Group, Vehicle Controlled, Multiple-Dose Study Of Tasocitinib (CP-690,550) In Subjects With Dry Eye Disease
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.
- Conditions
- Keratoconjunctivitis Sicca
- Being tested
- Tasocitinib, vehicle for Tasocitinib
- Keywords
- Dry Eye, Schirmer test, corneal staining, OSDI, OCI
- Medical subject headings
- Keratoconjunctivitis Sicca, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TasocitinibDrug
0.005% QD for 12 weeks
TasocitinibDrug
0.003% QD for 12 weeks
vehicle for TasocitinibDrug
vehicle QD for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tasocitinib 0.005% QD | Experimental | Not described Receives: Drug: Tasocitinib |
| Tasocitinib 0.003% QD | Experimental | Not described Receives: Drug: Tasocitinib |
| Vehicle for Tasocitinib | Placebo comparator | Not described Receives: Drug: vehicle for Tasocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in length of wetting of Schirmer test strip without anesthesia from baseline
Measured: Week 12
Change in Ocular Surface Disease Index's Environmental Trigger (OSDI-ET) subscale score from baseline
Measured: Week 12
Secondary outcomes (10)
Systemic safety: adverse events, clinical laboratory; and vital signs
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks
staining
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study start1 Dec 2010
- Primary completion19 Oct 2012 (estimated)
- Study completion19 Oct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratoconjunctivitis SiccaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226680
- Sponsor's protocol ID
- A3921066
- Status last verified
- Nov 2018
- First submitted
- 20 Oct 2010
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double Masked, Parallel Group, Vehicle Controlled, Multiple-Dose Study Of Tasocitinib (CP-690,550) In Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT01226680
- Acronym / sponsor ID
- A3921066
- Conditions
- Keratoconjunctivitis Sicca
- Keywords
- Dry Eye, Schirmer test, corneal staining, OSDI, OCI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2010 (actual)
- Primary completion
- 19 Oct 2012 (estimated)
- Study completion
- 19 Oct 2012 (estimated)
- First posted
- 22 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tasocitinib 0.005% QD | Experimental | Drug: Tasocitinib |
| Tasocitinib 0.003% QD | Experimental | Drug: Tasocitinib |
| Vehicle for Tasocitinib | Placebo comparator | Drug: vehicle for Tasocitinib |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Tasocitinib0.005% QD for 12 weeks | Drug | Tasocitinib 0.005% QD |
| Tasocitinib0.003% QD for 12 weeks | Drug | Tasocitinib 0.003% QD |
| vehicle for Tasocitinibvehicle QD for 12 weeks | Drug | Vehicle for Tasocitinib |
Primary outcome
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
10 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tasocitinib in people with Keratoconjunctivitis Sicca, run by Pfizer.
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 4 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: withdrawn, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in length of wetting of Schirmer test strip without anesthesia from baseline (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2018.