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

Condition(s) targeted: Glaucoma

Intervention: Timolol (Drug); latanoprost (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)

Secondary outcome:

Reduction From Baseline in Mean IOP at Week 1

Reduction From Baseline in Mean IOP at Week 4

Reduction From Baseline in Mean IOP at Week 12 (Observed)

Mean IOP at Baseline

Mean IOP at Week 1

Mean IOP at Week 4

Mean IOP at Week 12

Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12

Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience

Minimum age: 36 Weeks. Maximum age: 18 Years. Gender(s): Both.

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

Pfizer Investigational Site, Leuven 3000, Belgium

Pfizer Investigational Site, Praha 5 150 06, Czech Republic

Pfizer Investigational Site, Lille Cedex 59037, France

Pfizer Investigational Site, Lyon 69437, France

Pfizer Investigational Site, Regenstauf 93128, Germany

Pfizer Investigational Site, Schorndorf 73614, Germany

Pfizer Investigational Site, Catania 95123, Italy

Pfizer Investigational Site, Milano 20162, Italy

Pfizer Investigational Site, Makati City 1200, Philippines

Pfizer Investigational Site, Mandaluyong City 1500, Philippines

Pfizer Investigational Site, Bialystok 15-274, Poland

Pfizer Investigational Site, Gdansk 80-211, Poland

Pfizer Investigational Site, Wroclaw 50-368, Poland

Pfizer Investigational Site, Coimbra 3000-548, Portugal

Pfizer Investigational Site, Lisboa 1649-035, Portugal

Pfizer Investigational Site, Lisboa 1169-019, Portugal

Pfizer Investigational Site, Lisboa 1169-097, Portugal

Pfizer Investigational Site, Porto 4099-001, Portugal

Pfizer Investigational Site, Moscow 119331, Russian Federation

Pfizer Investigational Site, St. Petersburg 194100, Russian Federation

Pfizer Investigational Site, Belgrade 11000, Serbia

Pfizer Investigational Site, Bratislava 83340, Slovakia

Pfizer Investigational Site, Ljubljana 1000, Slovenia

Pfizer Investigational Site, Myfair West 2109, South Africa

Pfizer Investigational Site, Madrid 28040, Spain

Pfizer Investigational Site, Sevilla 41013, Spain

Pfizer Investigational Site, Kharkiv 61000, Ukraine

Pfizer Investigational Site, Kyiv 01135, Ukraine

Pfizer Investigational Site, Kyiv 04050, Ukraine

Pfizer Investigational Site, Kyiv, Ukraine

Pfizer Investigational Site, Odesa 65061, Ukraine

Pfizer Investigational Site, Birmingham B18 7QH, United Kingdom

Pfizer Investigational Site, London EC1V 2PD, United Kingdom

Pfizer Investigational Site, Hyderabad, Andhra Pradesh 500034, India

Pfizer Investigational Site, Medellín, Antioquia 0000, Colombia

Pfizer Investigational Site, Esplugues de Llobregat, Barcelona 08950, Spain

Pfizer Investigational Site, Amiens, Cedex 1 80054, France

Pfizer Investigational Site, Cluj-Napoca, Cluj 400006, Romania

Pfizer Investigational Site, Bogota, Cundinamarca 0000, Colombia

Pfizer Investigational Site, Pembroke Pines, Florida 33028, United States

Pfizer Investigational Site, Atlanta, Georgia 30322, United States

Pfizer Investigational Site, Ahmedabad, Gujarat 380004, India

Pfizer Investigational Site, Indianapolis, Indiana 46202, United States

Pfizer Investigational Site, Minneapolis, Minnesota 55455, United States

Pfizer Investigational Site, Henderson, Nevada 89074, United States

Pfizer Investigational Site, Henderson, Nevada 89052, United States

Pfizer Investigational Site, Las Vegas, Nevada 89148, United States

Pfizer Investigational Site, Coimbatore, Tamilnadu 641 014, India

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

Starting date: July 2008
Last updated: January 31, 2011