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

NCT00784719

Last updated date
Study Location
Pfizer Investigational Site
Chandler, Arizona, 85286, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Dry Eye Syndromes
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Symptoms of dry eye for at least 6 months.

- Signs of moderate to severe dry eye

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Dry Eye SyndromesA Prospective, Randomized, Placebo and Active Comparator Controlled Study of CP-690,550 in Subjects With Dry Eye.
NCT00784719
  1. Chandler, Arizona
  2. Peoria, Arizona
  3. Phoenix, Arizona
  4. Artesia, California
  5. Centennial, Colorado
  6. Ormond Beach, Florida
  7. Stuart, Florida
  8. Tamarac, Florida
  9. Tampa, Florida
  10. Atlanta, Georgia
  11. Morrow, Georgia
  12. Roswell, Georgia
  13. Louisville, Kentucky
  14. Baltimore, Maryland
  15. Boston, Massachusetts
  16. Kansas City, Missouri
  17. Lynbrook, New York
  18. Rochester, New York
  19. Charlotte, North Carolina
  20. High Point, North Carolina
  21. Cleveland, Ohio
  22. Columbus, Ohio
  23. Memphis, Tennessee
  24. Austin, Texas
  25. Austin, Texas
  26. Austin, Texas
  27. San Antonio, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Prospective, Randomized, Placebo and Active Comparator Controlled Study of CP-690,550 in Subjects With Dry Eye.
Official Title  ICMJE 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.
Brief Summary A prospective, randomized, placebo and active comparator controlled study of CP-690,550 in subjects with dry eye.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Syndromes
Intervention  ICMJE
  • Drug: CP-690,550
    Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks
  • Drug: CP-690,550
    Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks
  • Drug: CP-690,550
    Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks
  • Drug: CP-690,550
    Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks
  • Drug: Cyclosporine
    Ophthalmic topical solution, 0.05%, dosed at least once/day, 8 weeks
  • Drug: CP-690,550 Vehicle
    Ophthalmic topical solution, dosed at least once/day, 8 weeks
Study Arms  ICMJE
  • Experimental: Treatment 1
    Intervention: Drug: CP-690,550
  • Experimental: Treatment 2
    Intervention: Drug: CP-690,550
  • Experimental: Treatment 3
    Intervention: Drug: CP-690,550
  • Experimental: Treatment 4
    Intervention: Drug: CP-690,550
  • Active Comparator: Active comparator
    Intervention: Drug: Cyclosporine
  • Placebo Comparator: Placebo
    Intervention: Drug: CP-690,550 Vehicle
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2013)
327
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2008)
412
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00784719
Other Study ID Numbers  ICMJE A3921034
A3921034
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP