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Trial record 1 of 1 for:    NCT00638742
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A Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost.

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ClinicalTrials.gov Identifier: NCT00638742
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE March 12, 2008
First Posted Date  ICMJE March 19, 2008
Last Update Posted Date February 2, 2021
Study Start Date  ICMJE May 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2008)
Plasma latanoprost acid concentrations at steady-state. [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2008)
Adverse events related to systemic exposure of latanoprost [ Time Frame: 1 Day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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