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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Ichinomiya, Aichi, Japan
Contact
1-800-718-1021
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

NCT01135511
Pfizer
Completed
A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease

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[email protected]

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A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Dry Eye Syndromes
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
285
April 2011
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Korea, Republic of
 
 
NCT01135511
A3921072
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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