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

Glaucoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716859
• Other study ID #: A6111137
• Status: Completed
• Phase: Phase 3
• Start date: July 2008
• Est. completion date: November 2009

Study information

• Verified date: January 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Weeks to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Timolol
Timolol 0.5% dosed twice-daily
• latanoprost
Latanoprost 0.005% ophthalmic solution dosed once-daily

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Leuven
Colombia	Pfizer Investigational Site	Bogota	Cundinamarca
Colombia	Pfizer Investigational Site	Medellín	Antioquia
Czechia	Pfizer Investigational Site	Praha 5
France	Pfizer Investigational Site	Amiens	Cedex 1
France	Pfizer Investigational Site	Lille Cedex
France	Pfizer Investigational Site	Lyon
Germany	Pfizer Investigational Site	Regenstauf
Germany	Pfizer Investigational Site	Schorndorf
India	Pfizer Investigational Site	Ahmedabad	Gujarat
India	Pfizer Investigational Site	Coimbatore	Tamilnadu
India	Pfizer Investigational Site	Hyderabad	Andhra Pradesh
Italy	Pfizer Investigational Site	Catania
Italy	Pfizer Investigational Site	Milano
Philippines	Pfizer Investigational Site	Makati City
Philippines	Pfizer Investigational Site	Mandaluyong City
Poland	Pfizer Investigational Site	Bialystok
Poland	Pfizer Investigational Site	Gdansk
Poland	Pfizer Investigational Site	Wroclaw
Portugal	Pfizer Investigational Site	Coimbra
Portugal	Pfizer Investigational Site	Lisboa
Portugal	Pfizer Investigational Site	Lisboa
Portugal	Pfizer Investigational Site	Lisboa
Portugal	Pfizer Investigational Site	Porto
Romania	Pfizer Investigational Site	Cluj-Napoca	Cluj
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	St. Petersburg
Serbia	Pfizer Investigational Site	Belgrade
Slovakia	Pfizer Investigational Site	Bratislava
Slovenia	Pfizer Investigational Site	Ljubljana
South Africa	Pfizer Investigational Site	Myfair West
Spain	Pfizer Investigational Site	Esplugues de Llobregat	Barcelona
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Sevilla
Ukraine	Pfizer Investigational Site	Kharkiv
Ukraine	Pfizer Investigational Site	Kyiv
Ukraine	Pfizer Investigational Site	Kyiv
Ukraine	Pfizer Investigational Site	Kyiv
Ukraine	Pfizer Investigational Site	Odesa
United Kingdom	Pfizer Investigational Site	Birmingham
United Kingdom	Pfizer Investigational Site	London
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Henderson	Nevada
United States	Pfizer Investigational Site	Henderson	Nevada
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	Pembroke Pines	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Colombia,  Czechia,  France,  Germany,  India,  Italy,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  Slovenia,  South Africa,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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