A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00716859

Purpose

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.

Condition	Intervention	Phase
Glaucoma	Drug: Timolol Drug: latanoprost	Phase III

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Timolol Timolol maleate Latanoprost

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	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.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Mean change from baseline intraocular pressure (IOP) in the study eye [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with at least a 15% IOP reduction from baseline in the study eye [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Proportion of subjects discontinuing therapy due to a drug-related adverse experience [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Mean IOP change from baseline in the study at each visit [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Mean IOP level in the study eye at each visit [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	July 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Timolol: Active Comparator	Drug: Timolol Latanoprost will be compared with timolol how effectively and safely lowers IOP in pediatric glaucoma patients
latanoprost: Experimental	Drug: latanoprost Latanoprost will be compared with timolol how effectively and safely lowers IOP in pediatric glaucoma patients

Eligibility

Ages Eligible for Study:	36 Weeks to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female of 18 years of age or under
Diagnosis of glaucoma
IOP of 22 mmHg or above in at least 1 eye

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716859

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 64 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6111137
Study First Received:	July 14, 2008
Last Updated:	April 13, 2009
ClinicalTrials.gov Identifier:	NCT00716859 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic Agents
Eye Diseases
Cardiovascular Agents
Latanoprost
Antihypertensive Agents
Glaucoma

Adrenergic beta-Antagonists
Adrenergic Antagonists
Timolol
Anti-Arrhythmia Agents
Ocular Hypertension
Hypertension

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Eye Diseases
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Latanoprost

Pharmacologic Actions
Glaucoma
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Timolol
Anti-Arrhythmia Agents
Ocular Hypertension

ClinicalTrials.gov processed this record on May 07, 2009