A Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost.
NCT00638742
ABOUT THIS STUDY
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- 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).
- 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.
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Descriptive Information | ||||
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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) | |||
Condition ICMJE |
| |||
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 | 47 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 | Director, Clinical Trial Disclosure Group, Pfizer Inc | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
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 |