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A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01135511
Recruitment Status : Completed
First Posted : June 2, 2010
Results First Posted : May 7, 2013
Last Update Posted : May 7, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: CP-690,550 Eye drops Drug: CP-690,550 Eye drops-vehicle Drug: Sodium Hyaluronate Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: Treatment 1 Drug: CP-690,550 Eye drops
Ophthalmic topical solution, low dose, dosed once/day, 8 weeks

Experimental: Treatment 2 Drug: CP-690,550 Eye drops
Ophthalmic topical solution, medium dose, dosed once/day, 8 weeks

Experimental: Treatment 3 Drug: CP-690,550 Eye drops
Ophthalmic topical solution, high dose, dosed once/day, 8 weeks

Placebo Comparator: Treatment 4 Drug: CP-690,550 Eye drops-vehicle
Ophthalmic topical solution, vehicle, dosed once/day, 8 weeks

Active Comparator: Treatment 5 Drug: Sodium Hyaluronate
Ophthalmic topical solution, dosed 6 times/day, 8 weeks




Primary Outcome Measures :
  1. Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8 [ Time Frame: Baseline, Week 8 ]

    Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 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. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.



Secondary Outcome Measures :
  1. Changes in Corneal Staining Scores for Study Eye From Baseline [ Time Frame: Baseline, Week 1, 2 and 4 ]

    Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 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. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.


  2. Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye [ Time Frame: Week 1, 2, 4 and 8 ]

    Percentage of participants demonstrating corneal staining score = 0 which indicates no damage in corneal surface.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.


  3. Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline [ Time Frame: Baseline, Week 1, 2, 4 and 8 ]

    Based on the Oxford grading system, the bulbar conjunctiva of each eye was divided into 2 different zones (nasal and temporal). The nasal and temporal bulbar conjunctival zones were each graded independently using a 6-point scale (0 [Absent] to 5 [Severe]). Total score ranged from 0 (Absent) to 10 (severe), higher score=higher damage to eyes due to dryness. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.


  4. Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline [ Time Frame: Baseline, Week 1, 2, 4 and 8 ]

    TBUT is the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Using a stopwatch, the time between last complete blink and first appearance of dry spot was recorded.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.


  5. Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline [ Time Frame: Baseline, Week 1, 2, 4 and 8 ]

    The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.


  6. Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye [ Time Frame: Week 1, 2, 4 and 8 ]

    The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.


  7. Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye [ Time Frame: Week 1, 2, 4 and 8 ]

    The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.


  8. Changes in the Ocular Comfort Index (OCI) Total Score From Baseline [ Time Frame: Baseline, Week 1, 2, 4 and 8 ]

    The OCI is a validated instrument developed 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 rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.


  9. Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline [ Time Frame: Week 1, 2, 4 and 8 ]

    The OCI is a validated instrument developed 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 rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.


  10. Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline [ Time Frame: Baseline, Week 1, 2, 4 and 8 ]

    The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.

    The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4].

    The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.


  11. Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms [ Time Frame: Baseline, Week 1, 2, 4 and 8 ]

    The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.

    The 12 items of the OSDI questionnaire were graded on a scale of 0 [the none of time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 1 to 3 answered) × 100]/[(total number of questions 1 to 3 answered) × 4].

    The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.


  12. Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function [ Time Frame: Baseline, Week 1, 2, 4 and 8 ]

    The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.

    The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 4 to 9 answered) × 100]/[(total number of questions 4 to 9 answered) × 4].

    Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.


  13. Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers [ Time Frame: Baseline, Week 1, 2, 4 and 8 ]

    The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.

    The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 10 to 12 answered) × 100]/[(total number of questions 10 to 12 answered) × 4].

    The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.


  14. Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline [ Time Frame: Week 1, 2, 4 and 8 ]

    The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.

    The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4].

    The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.


  15. Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye [ Time Frame: Week 8 ]

    Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale. The maximum possible staining score is 15, higher score indicated greater staining.

    100% Clearing of Corneal Staining means corneal staining score = 0. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.


  16. Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye [ Time Frame: Week 8 ]

    The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.


  17. Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores [ Time Frame: Week 8 ]
    The OCI is a validated instrument developed 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 rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Negative change from baseline indicated improvement. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

  18. Number of Participants With Ocular Adverse Events (AEs)by Severity [ Time Frame: 8 weeks ]
    Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Ocular AEs are the events which are localized in the ocular region. Participants with multiple occurrences of an AE within a category were counted once within the category.

  19. Number of Participants With Nonocular Adverse Events (AEs) by Severity [ Time Frame: 8 weeks ]
    Counts of participants who had treatment-emergent nonocular AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.

  20. Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale [ Time Frame: 8 weeks ]

    Ocular tolerability was assessed for the 5 symptoms (burning sensation, blurred vision, ocular discomfort, pain, tearing), based on a 4-point severity scale (none, minor, moderate, and severe).

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.



Other Outcome Measures:
  1. Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye [ Time Frame: Baseline, Week 4 and 8 ]

    The average level of HLA-DR expression per cell was reported as HLA-DR antibody bound per cell (ABC).

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change = value at observation minus value at baseline.


  2. Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye [ Time Frame: Baseline, Week 4 and 8 ]

    Percentage of conjunctival epithelial cells that were positive with HLA-DR expression was calculated as HLA-DR Positive.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.


  3. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3 [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  4. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18 [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  5. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6 [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  6. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7 [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  7. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8 [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  8. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1 [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  9. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70) [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  10. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  11. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  12. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23 [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  13. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3 [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  14. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9 [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  15. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  16. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  17. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  18. 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) [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  19. 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) [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  20. 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) [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  21. 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) [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  22. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  23. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  24. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  25. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  26. Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4 [ Time Frame: Week 4 and 8 ]

    Number of analyzed with sufficient quantity for analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.


  27. Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125 [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  28. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1 [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  29. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1 [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.


  30. Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein [ Time Frame: Baseline, Week 4 and 8 ]

    Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

    Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

    Change= value at visit minus value at baseline.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135511


Locations
Layout table for location information
Japan
Pfizer Investigational Site
Ichinomiya, Aichi, Japan
Pfizer Investigational Site
Narashino, Chiba, Japan
Pfizer Investigational Site
Urayasu, Chiba, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Yokohama, Kangawa, Japan
Pfizer Investigational Site
Fuji, Shizuoka, Japan
Pfizer Investigational Site
Numazu, Shizuoka, Japan
Pfizer Investigational Site
Susono, Shizuoka, Japan
Pfizer Investigational Site
Chiyoda-ku, Tokyo, Japan
Pfizer Investigational Site
Hamura, Tokyo, Japan
Pfizer Investigational Site
Minato-ku, Tokyo, Japan
Pfizer Investigational Site
Ohta-ku, Tokyo, Japan
Pfizer Investigational Site
Sumida-ku, Tokyo, Japan
Pfizer Investigational Site
Tachikawa, Tokyo, Japan
Pfizer Investigational Site
Taito-ku, Tokyo, Japan
Pfizer Investigational Site
Chiba, Japan
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Kyoto, Japan
Pfizer Investigational Site
Osaka, Japan
Pfizer Investigational Site
Shizuoka, Japan
Pfizer Investigational Site
Tokyo, Japan
Korea, Republic of
Pfizer Investigational Site
Gwangju, Korea, Republic of, 501-757
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site
Seoul, Korea, Republic of, 136-705
Pfizer Investigational Site
Seoul, Korea, Republic of, 137-701
Pfizer Investigational Site
Seoul, Korea, Republic of
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01135511     History of Changes
Other Study ID Numbers: A3921072
First Posted: June 2, 2010    Key Record Dates
Results First Posted: May 7, 2013
Last Update Posted: May 7, 2013
Last Verified: March 2013

Keywords provided by Pfizer:
Dry eye

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Tofacitinib
Hyaluronic Acid
Pharmaceutical Solutions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents