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

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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.

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Timolol Timolol maleate Latanoprost

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
Calculated as Baseline IOP minus Week 12 IOP, LOCF. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were less than or equal to (≤) 2 millimeters of mercury (mmHg) of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.

Secondary Outcome Measures:

Reduction From Baseline in Mean IOP at Week 1 [ Time Frame: Baseline, Week 1 ] [ Designated as safety issue: No ]
Calculated as Baseline IOP minus Week 1 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Reduction From Baseline in Mean IOP at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
Calculated as Baseline IOP minus Week 4 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Reduction From Baseline in Mean IOP at Week 12 (Observed) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
Calculated as Baseline IOP minus Week 12 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Mean IOP at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Mean IOP at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Mean IOP at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Mean IOP at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12 [ Time Frame: Baseline, Week 4, and Week 12 ] [ Designated as safety issue: No ]
Participants with ≥15% IOP reduction from baseline at both Week 4 and Week 12. Calculated as (post baseline IOP minus baseline IOP) divided by IOP, multiplied by 100%. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: Yes ]
An investigator's causality assessment was the determination of whether there existed a reasonable possibility that the investigational product caused or contributed to an adverse event (AE). If the investigator did not know whether or not investigational product caused the event, then the event was handled as "related to investigational product" for reporting purposes.

Enrollment:	139
Study Start Date:	July 2008
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Timolol	Drug: Timolol Timolol 0.5% dosed twice-daily
Experimental: latanoprost	Drug: latanoprost Latanoprost 0.005% ophthalmic solution dosed once-daily

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

Show 48 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:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00716859 History of Changes
Other Study ID Numbers:	A6111137
Study First Received:	July 14, 2008
Results First Received:	November 1, 2010
Last Updated:	January 31, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Glaucoma
Ocular Hypertension
Eye Diseases
Timolol
Latanoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 19, 2013