A Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost.

Back to Search
Print
Bookmark Trial

NCT00638742

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Artesia, California, 90701, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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

- This study will enroll pediatric and adult subjects with glaucoma or ocular hypertension receiving treatment with latanoprost in either one or both eyes for at least two weeks.

- The pediatric subjects will be grouped by age (0 to <3 years, 3 to <12 years, 12 to 18 years).

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


- Ocular inflammation/infection or a history of ocular inflammation/infection within 3
months prior to the screening visit.


- History of ocular trauma or surgery in either eye within 14-days of the screening
visit.


- Use of continuous wear contact lenses.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Glaucoma, Ocular HypertensionStudy to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops
NCT00402493
  1. Willingboro, New Jersey
  2. Philadelphia, Pennsylvania
  3. Philadelphia, Pennsylvania
ALL GENDERS
21 Years+
years
MULTIPLE SITES
Glaucoma, Ocular HypertensionNon-Interventional Study In Patients With Ocular Hypertension And Open Angle Glaucoma Treated With Xalatan And Xalacom
NCT01012245
ALL GENDERS
0+
years
MULTIPLE SITES
Glaucoma, Ocular HypertensionA Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost.
NCT00638742
  1. Artesia, California
  2. Atlanta, Georgia
  3. Atlanta, Georgia
  4. North Dartmouth, Massachusetts
  5. Minneapolis, Minnesota
  6. Durham, North Carolina
  7. Koebenhavn OE,
  8. Catania,
  9. Coimbra,
  10. Lisboa,
  11. Mayfair West,
  12. Madrid,
  13. Madrid,
ALL GENDERS
0+
years
MULTIPLE SITES
Glaucoma, Ocular HypertensionComparison of Latanoprost With Travoprost and Bimatoprost in Patients With Elevated IOP. A 12-Weeks, Masked Evaluator, Phase IV Multi-Center Study in the US
NCT00847483
  1. Belleflower, California
  2. Inglewood, California
  3. San Diego, California
  4. San Diego, California
  5. San Francisco, California
  6. Gainesville, Florida
  7. Lakeland, Florida
  8. Ormond Beach, Florida
  9. Atlanta, Georgia
  10. Bloomingdale, Illinois
  11. Evansville, Indiana
  12. Louisville, Kentucky
  13. Louisville, Kentucky
  14. Shreveport, Louisiana
  15. Bangor, Maine
  16. Kansas City, Missouri
  17. Kansas City, Missouri
  18. Omaha, Nebraska
  19. Las Vegas, Nevada
  20. Bloomfield, New Jersey
  21. Willingboro, New Jersey
  22. Charlotte, North Carolina
  23. Winston-Salem, North Carolina
  24. Streetsboro, Ohio
  25. Oklahoma City, Oklahoma
  26. Tulsa, Oklahoma
  27. Pittsburgh, Pennsylvania
  28. Charleston, South Carolina
  29. Charleston, South Carolina
  30. Charleston, South Carolina
  31. Maryville, Tennessee
  32. Memphis, Tennessee
  33. Dallas, Texas
  34. El Paso, Texas
  35. Houston, Texas
  36. Layton, Utah
  37. Norfolk, Virginia
  38. Norfolk, Virginia
  39. Virginia Beach, Virginia
  40. Wenatchee, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost.
Official Title  ICMJE A Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost 0.005%.
Brief Summary To evaluate the steady-state systemic plasma concentrations of latanoprost acid following administration of latanoprost 0.005% (1.5 ug) in pediatric and adult subjects with glaucoma or ocular hypertension.
Detailed Description Pharmacokinetics and Safety
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Glaucoma
  • Ocular Hypertension
Intervention  ICMJE Drug: latanoprost
latanoprost 0.005% (1.5 ug) will be administered. A single drop of latanoprost 0.005% will be instilled into both eyes by the investigator.
Study Arms  ICMJE Experimental: 1
Intervention: Drug: latanoprost
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: December 29, 2010)		47
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2008)		30
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • This study will enroll pediatric and adult subjects with glaucoma or ocular hypertension receiving treatment with latanoprost in either one or both eyes for at least two weeks.
  • The pediatric subjects will be grouped by age (0 to <3 years, 3 to <12 years, 12 to 18 years).

Exclusion Criteria:

  • Ocular inflammation/infection or a history of ocular inflammation/infection within 3 months prior to the screening visit.
  • History of ocular trauma or surgery in either eye within 14-days of the screening visit.
  • Use of continuous wear contact lenses.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE Child, 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 Denmark,   Italy,   Portugal,   South Africa,   Spain,   United States
Removed Location Countries Greece
 
Administrative Information
NCT Number  ICMJE NCT00638742
Other Study ID Numbers  ICMJE A6111139
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2010

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