Clinical trial NCT01135511: A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease
Official title: A Phase II, Prospective, Randomized, Double Masked/Investigator Masked, Vehicle And Comparator (Sodium Hyaluronate Eye Drops) Controlled, Dose Ranging Study Of CP-690,550 Eye Drops In Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Keywords: Dry eye
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-06-02
Enrollment: 285
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye drops in patients with dry eye disease.


Eligibility criteria: Inclusion Criteria:

* Subjective symptoms of dry eye for at least 6 months
* Signs of moderate to severe dry eye (corneal staining score and schirmer test without anesthesia)

Exclusion Criteria:

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

Primary outcomes:
measure: Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Changes in Corneal Staining Scores for Study Eye From Baseline
timeFrame: Baseline, Week 1, 2 and 4
measure: Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye
timeFrame: Week 1, 2, 4 and 8
measure: Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline
timeFrame: Baseline, Week 1, 2, 4 and 8
measure: Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline
timeFrame: Baseline, Week 1, 2, 4 and 8
measure: Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline
timeFrame: Baseline, Week 1, 2, 4 and 8
measure: Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye
timeFrame: Week 1, 2, 4 and 8
measure: Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye
timeFrame: Week 1, 2, 4 and 8
measure: Changes in the Ocular Comfort Index (OCI) Total Score From Baseline
timeFrame: Baseline, Week 1, 2, 4 and 8
measure: Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline
timeFrame: Week 1, 2, 4 and 8
measure: Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline
timeFrame: Baseline, Week 1, 2, 4 and 8
measure: Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms
timeFrame: Baseline, Week 1, 2, 4 and 8
measure: Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function
timeFrame: Baseline, Week 1, 2, 4 and 8
measure: Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers
timeFrame: Baseline, Week 1, 2, 4 and 8
measure: Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline
timeFrame: Week 1, 2, 4 and 8
measure: Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye
timeFrame: Week 8
measure: Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye
timeFrame: Week 8
measure: Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores
timeFrame: Week 8
measure: Number of Participants With Ocular Adverse Events (AEs)by Severity
timeFrame: 8 weeks
measure: Number of Participants With Nonocular Adverse Events (AEs) by Severity
timeFrame: 8 weeks
measure: Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
timeFrame: 8 weeks
Other outcomes:
measure: Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye
timeFrame: Baseline, Week 4 and 8
measure: Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70)
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10)
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG)
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A)
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES)
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1)
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC
timeFrame: Baseline, Week 4 and 8
measure: Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4
timeFrame: Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1
timeFrame: Baseline, Week 4 and 8
measure: Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein
timeFrame: Baseline, Week 4 and 8
Locations:
city: Ichinomiya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Narashino
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Urayasu
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kangawa
city: Fuji
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Numazu
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Susono
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Chiyoda-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Hamura
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Ohta-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Sumida-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Tachikawa
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Taito-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chiba
country: Japan
facility: Pfizer Investigational Site
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Kyoto
country: Japan
facility: Pfizer Investigational Site
city: Osaka
country: Japan
facility: Pfizer Investigational Site
city: Shizuoka
country: Japan
facility: Pfizer Investigational Site
city: Tokyo
country: Japan
facility: Pfizer Investigational Site
city: Gwangju
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: