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

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.

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Drug: Timolol; Drug: latanoprost

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)	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.	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction From Baseline in Mean IOP at 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.	Baseline, Week 1
Reduction From Baseline in Mean IOP at 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.	Baseline, Week 4
Reduction From Baseline in Mean IOP at Week 12 (Observed)	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.	Baseline, Week 12
Mean IOP at 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.	Baseline
Mean IOP at 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.	Week 1
Mean IOP at 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.	Week 4
Mean IOP at 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.	Week 12
Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 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.	Baseline, Week 4, and Week 12
Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience	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.	Baseline through Week 12

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: July 14, 2008
• First Submitted That Met QC Criteria: July 14, 2008
• First Posted (Estimate): July 16, 2008

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Timolol; Latanoprost
• Other Study ID Numbers: A6111137