A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.
NCT00716859
ABOUT THIS STUDY
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1-800-718-1021
- Male or female of 18 years of age or under
- Diagnosis of glaucoma
- IOP of 22 mmHg or above in at least 1 eye
- Require surgery for acute angle closure
- Have had prior cyclodestructive procedures
- Have a history of ocular trauma or surgery in either eye within 3 months of the
baseline visit
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Descriptive Information | ||||
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Brief Title ICMJE | A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma. | |||
Official Title ICMJE | A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study Evaluating The Efficacy And Safety Of Latanoprost And Timolol In Pediatric Subjects With Glaucoma. | |||
Brief Summary | To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Glaucoma | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | 139 | |||
Original Estimated Enrollment ICMJE | 120 | |||
Actual Study Completion Date ICMJE | November 2009 | |||
Actual Primary Completion Date | November 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 36 Weeks to 18 Years (Child, Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Colombia, Czech Republic, France, Germany, India, Italy, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Ukraine, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00716859 | |||
Other Study ID Numbers ICMJE | A6111137 | |||
Has Data Monitoring Committee | Yes | |||
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 |
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PRS Account | Pfizer | |||
Verification Date | January 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |