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

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Timolol
latanoprost
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

36 Weeks - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Timolol

latanoprost

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 14, 2008
Last Updated
February 1, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00716859
Brief Title
A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.
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 Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Timolol
Arm Type
Active Comparator
Arm Title
latanoprost
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Timolol
Intervention Description
Timolol 0.5% dosed twice-daily
Intervention Type
Drug
Intervention Name(s)
latanoprost
Intervention Description
Latanoprost 0.005% ophthalmic solution dosed once-daily
Primary Outcome Measure Information:
Title
Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)
Description
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.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Reduction From Baseline in Mean IOP at Week 1
Description
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.
Time Frame
Baseline, Week 1
Title
Reduction From Baseline in Mean IOP at Week 4
Description
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.
Time Frame
Baseline, Week 4
Title
Reduction From Baseline in Mean IOP at Week 12 (Observed)
Description
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.
Time Frame
Baseline, Week 12
Title
Mean IOP at Baseline
Description
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.
Time Frame
Baseline
Title
Mean IOP at Week 1
Description
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.
Time Frame
Week 1
Title
Mean IOP at Week 4
Description
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.
Time Frame
Week 4
Title
Mean IOP at Week 12
Description
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.
Time Frame
Week 12
Title
Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12
Description
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.
Time Frame
Baseline, Week 4, and Week 12
Title
Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience
Description
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.
Time Frame
Baseline through Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Weeks
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Pfizer Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Pfizer Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Pfizer Investigational Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Pfizer Investigational Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Pfizer Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Amiens
State/Province
Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
Pfizer Investigational Site
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Pfizer Investigational Site
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Pfizer Investigational Site
City
Regenstauf
ZIP/Postal Code
93128
Country
Germany
Facility Name
Pfizer Investigational Site
City
Schorndorf
ZIP/Postal Code
73614
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
Facility Name
Pfizer Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380004
Country
India
Facility Name
Pfizer Investigational Site
City
Coimbatore
State/Province
Tamilnadu
ZIP/Postal Code
641 014
Country
India
Facility Name
Pfizer Investigational Site
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Pfizer Investigational Site
City
Makati City
ZIP/Postal Code
1200
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Mandaluyong City
ZIP/Postal Code
1500
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Bialystok
ZIP/Postal Code
15-274
Country
Poland
Facility Name
Pfizer Investigational Site
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Pfizer Investigational Site
City
Wroclaw
ZIP/Postal Code
50-368
Country
Poland
Facility Name
Pfizer Investigational Site
City
Coimbra
ZIP/Postal Code
3000-548
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Lisboa
ZIP/Postal Code
1169-019
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Lisboa
ZIP/Postal Code
1169-097
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400006
Country
Romania
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
119331
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
83340
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Pfizer Investigational Site
City
Myfair West
ZIP/Postal Code
2109
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Pfizer Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Pfizer Investigational Site
City
Kharkiv
ZIP/Postal Code
61000
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kyiv
ZIP/Postal Code
01135
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kyiv
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Odesa
ZIP/Postal Code
65061
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Birmingham
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6111137&StudyName=A%20Phase%203%20Prospective%2C%20Randomized%2C%20Double-Masked%2C%2012-Week%2C%20Parallel%20Group%20Study%20In%20Pediatric%20Subjects%20With%20Glaucoma.
Description
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A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.

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