Clinical trial NCT00716859: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-16
Enrollment: 139
Sex: ALL
Minimum age (years): 36
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Reduction From Baseline in Mean IOP at Week 1
timeFrame: Baseline, Week 1
measure: Reduction From Baseline in Mean IOP at Week 4
timeFrame: Baseline, Week 4
measure: Reduction From Baseline in Mean IOP at Week 12 (Observed)
timeFrame: Baseline, Week 12
measure: Mean IOP at Baseline
timeFrame: Baseline
measure: Mean IOP at Week 1
timeFrame: Week 1
measure: Mean IOP at Week 4
timeFrame: Week 4
measure: Mean IOP at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12
timeFrame: Baseline, Week 4, and Week 12
measure: Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience
timeFrame: Baseline through Week 12
Other outcomes:
Locations:
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Medellín
country: Colombia
facility: Pfizer Investigational Site
state: Antioquia
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Praha 5
country: Czechia
facility: Pfizer Investigational Site
city: Amiens
country: France
facility: Pfizer Investigational Site
state: Cedex 1
city: Lille Cedex
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Regenstauf
country: Germany
facility: Pfizer Investigational Site
city: Schorndorf
country: Germany
facility: Pfizer Investigational Site
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Coimbatore
country: India
facility: Pfizer Investigational Site
state: Tamilnadu
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Makati City
country: Philippines
facility: Pfizer Investigational Site
city: Mandaluyong City
country: Philippines
facility: Pfizer Investigational Site
city: Bialystok
country: Poland
facility: Pfizer Investigational Site
city: Gdansk
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: Coimbra
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Cluj-Napoca
country: Romania
facility: Pfizer Investigational Site
state: Cluj
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Belgrade
country: Serbia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Ljubljana
country: Slovenia
facility: Pfizer Investigational Site
city: Myfair West
country: South Africa
facility: Pfizer Investigational Site
city: Esplugues de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Odesa
country: Ukraine
facility: Pfizer Investigational Site
city: Birmingham
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: