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

NCT01135511

Last updated date
Study Location
Pfizer Investigational Site
Ichinomiya, Aichi, , Japan
Contact
1-800-718-1021

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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
20 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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


- 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

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Dry Eye SyndromesA Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease NCT01135511
  1. Ichinomiya, Aichi
  2. Narashino, Chiba
  3. Urayasu, Chiba
  4. Yokohama, Kanagawa
  5. Yokohama, Kangawa
  6. Fuji, Shizuoka
  7. Numazu, Shizuoka
  8. Susono, Shizuoka
  9. Chiyoda-ku, Tokyo
  10. Hamura, Tokyo
  11. Minato-ku, Tokyo
  12. Ohta-ku, Tokyo
  13. Sumida-ku, Tokyo
  14. Tachikawa, Tokyo
  15. Taito-ku, Tokyo
  16. Chiba,
  17. Fukuoka,
  18. Kyoto,
  19. Osaka,
  20. Shizuoka,
  21. Tokyo,
  22. Gwangju,
  23. Seoul,
  24. Seoul,
  25. Seoul,
  26. Seoul,
  27. Seoul,
ALL GENDERS
20 Years+
years
MULTIPLE SITES
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 Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE 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 Eye drops
    Ophthalmic topical solution, low dose, dosed once/day, 8 weeks
  • Drug: CP-690,550 Eye drops
    Ophthalmic topical solution, medium dose, dosed once/day, 8 weeks
  • Drug: CP-690,550 Eye drops
    Ophthalmic topical solution, high dose, dosed once/day, 8 weeks
  • Drug: CP-690,550 Eye drops-vehicle
    Ophthalmic topical solution, vehicle, dosed once/day, 8 weeks
  • Drug: Sodium Hyaluronate
    Ophthalmic topical solution, dosed 6 times/day, 8 weeks
Study Arms  ICMJE
  • Experimental: Treatment 1
    Intervention: Drug: CP-690,550 Eye drops
  • Experimental: Treatment 2
    Intervention: Drug: CP-690,550 Eye drops
  • Experimental: Treatment 3
    Intervention: Drug: CP-690,550 Eye drops
  • Placebo Comparator: Treatment 4
    Intervention: Drug: CP-690,550 Eye drops-vehicle
  • Active Comparator: Treatment 5
    Intervention: Drug: Sodium Hyaluronate
Publications * Not Provided

*   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 14, 2012)
285
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2010)
280
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 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 Japan,   Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01135511
Other Study ID Numbers  ICMJE A3921072
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 March 2013

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