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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00716859
Recruitment Status : Completed
First Posted : July 16, 2008
Results First Posted : December 2, 2010
Last Update Posted : February 2, 2011
Sponsor:
Information provided by:
Pfizer

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.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: Timolol Drug: latanoprost Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : July 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: Timolol Drug: Timolol
Timolol 0.5% dosed twice-daily

Experimental: latanoprost Drug: latanoprost
Latanoprost 0.005% ophthalmic solution dosed once-daily




Primary Outcome Measures :
  1. Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF) [ Time Frame: Baseline, Week 12 ]
    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 :
  1. Reduction From Baseline in Mean IOP at Week 1 [ Time Frame: Baseline, Week 1 ]
    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.

  2. Reduction From Baseline in Mean IOP at Week 4 [ Time Frame: Baseline, Week 4 ]
    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.

  3. Reduction From Baseline in Mean IOP at Week 12 (Observed) [ Time Frame: Baseline, Week 12 ]
    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.

  4. Mean IOP at Baseline [ Time Frame: Baseline ]
    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.

  5. Mean IOP at Week 1 [ Time Frame: Week 1 ]
    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.

  6. Mean IOP at Week 4 [ Time Frame: Week 4 ]
    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.

  7. Mean IOP at Week 12 [ Time Frame: Week 12 ]
    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.

  8. 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 ]
    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.

  9. Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience [ Time Frame: Baseline through Week 12 ]
    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.



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Ages Eligible for Study:   36 Weeks to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716859


Locations
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United States, Florida
Pfizer Investigational Site
Pembroke Pines, Florida, United States, 33028
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30322
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55455
United States, Nevada
Pfizer Investigational Site
Henderson, Nevada, United States, 89052
Pfizer Investigational Site
Henderson, Nevada, United States, 89074
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89148
Belgium
Pfizer Investigational Site
Leuven, Belgium, 3000
Colombia
Pfizer Investigational Site
Medellín, Antioquia, Colombia, 0000
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia, 0000
Czech Republic
Pfizer Investigational Site
Praha 5, Czech Republic, 150 06
France
Pfizer Investigational Site
Amiens, Cedex 1, France, 80054
Pfizer Investigational Site
Lille Cedex, France, 59037
Pfizer Investigational Site
Lyon, France, 69437
Germany
Pfizer Investigational Site
Regenstauf, Germany, 93128
Pfizer Investigational Site
Schorndorf, Germany, 73614
India
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500034
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380004
Pfizer Investigational Site
Coimbatore, Tamilnadu, India, 641 014
Italy
Pfizer Investigational Site
Catania, Italy, 95123
Pfizer Investigational Site
Milano, Italy, 20162
Philippines
Pfizer Investigational Site
Makati City, Philippines, 1200
Pfizer Investigational Site
Mandaluyong City, Philippines, 1500
Poland
Pfizer Investigational Site
Bialystok, Poland, 15-274
Pfizer Investigational Site
Gdansk, Poland, 80-211
Pfizer Investigational Site
Wroclaw, Poland, 50-368
Portugal
Pfizer Investigational Site
Coimbra, Portugal, 3000-548
Pfizer Investigational Site
Lisboa, Portugal, 1169-019
Pfizer Investigational Site
Lisboa, Portugal, 1169-097
Pfizer Investigational Site
Lisboa, Portugal, 1649-035
Pfizer Investigational Site
Porto, Portugal, 4099-001
Romania
Pfizer Investigational Site
Cluj-Napoca, Cluj, Romania, 400006
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 119331
Pfizer Investigational Site
St. Petersburg, Russian Federation, 194100
Serbia
Pfizer Investigational Site
Belgrade, Serbia, 11000
Slovakia
Pfizer Investigational Site
Bratislava, Slovakia, 83340
Slovenia
Pfizer Investigational Site
Ljubljana, Slovenia, 1000
South Africa
Pfizer Investigational Site
Myfair West, South Africa, 2109
Spain
Pfizer Investigational Site
Esplugues de Llobregat, Barcelona, Spain, 08950
Pfizer Investigational Site
Madrid, Spain, 28040
Pfizer Investigational Site
Sevilla, Spain, 41013
Ukraine
Pfizer Investigational Site
Kharkiv, Ukraine, 61000
Pfizer Investigational Site
Kyiv, Ukraine, 01135
Pfizer Investigational Site
Kyiv, Ukraine, 04050
Pfizer Investigational Site
Kyiv, Ukraine
Pfizer Investigational Site
Odesa, Ukraine, 65061
United Kingdom
Pfizer Investigational Site
Birmingham, United Kingdom, B18 7QH
Pfizer Investigational Site
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00716859    
Other Study ID Numbers: A6111137
First Posted: July 16, 2008    Key Record Dates
Results First Posted: December 2, 2010
Last Update Posted: February 2, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Timolol
Latanoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents