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

NCT00716859 | Completed Phase 3 Results DMC

• 1 other identifier: A6111137
• Study Type: interventional
• Target: 139
• Locations: 19 countries
• Sites: 47

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Reduction From Baseline in Mean IOP at Week 1

  Baseline, Week 1

• Reduction From Baseline in Mean IOP at Week 4

  Baseline, Week 4

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

  Baseline, Week 12

• Mean IOP at Baseline

  Baseline

• Mean IOP at Week 1

  Week 1

Study Arms (2)

Timolol

ACTIVE COMPARATOR

Drug: Timolol

latanoprost

EXPERIMENTAL

Drug: latanoprost

Interventions

Timolol DRUG

Timolol 0.5% dosed twice-daily

Timolol

latanoprost DRUG

Latanoprost 0.005% ophthalmic solution dosed once-daily

latanoprost

Eligibility Criteria

• Age: 36 Weeks - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female of 18 years of age or under
• Diagnosis of glaucoma
• IOP of 22 mmHg or above in at least 1 eye

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (48)

Pfizer Investigational Site

Pembroke Pines, Florida, 33028, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30322, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46202, United States

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Minneapolis, Minnesota, 55455, United States

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Henderson, Nevada, 89052, United States

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Pfizer Investigational Site

Henderson, Nevada, 89074, United States

Location

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Las Vegas, Nevada, 89148, United States

Location

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Leuven, 3000, Belgium

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Medellín, Antioquia, 0000, Colombia

Location

Pfizer Investigational Site

Bogota, Cundinamarca, 0000, Colombia

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Prague, 150 06, Czechia

Location

Pfizer Investigational Site

Amiens, Cedex 1, 80054, France

Location

Pfizer Investigational Site

Lille, 59037, France

Location

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Lyon, 69437, France

Location

Pfizer Investigational Site

Regenstauf, 93128, Germany

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Pfizer Investigational Site

Schorndorf, 73614, Germany

Location

Pfizer Investigational Site

Hyderabad, Andhra Pradesh, 500034, India

Location

Pfizer Investigational Site

Ahmedabad, Gujarat, 380004, India

Location

Pfizer Investigational Site

Coimbatore, Tamil Nadu, 641 014, India

Location

Pfizer Investigational Site

Catania, 95123, Italy

Location

Pfizer Investigational Site

Milan, 20162, Italy

Location

Pfizer Investigational Site

Makati City, 1200, Philippines

Location

Pfizer Investigational Site

Mandaluyong, 1500, Philippines

Location

Pfizer Investigational Site

Bialystok, 15-274, Poland

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Gdansk, 80-211, Poland

Location

Pfizer Investigational Site

Wroclaw, 50-368, Poland

Location

Pfizer Investigational Site

Coimbra, 3000-548, Portugal

Location

Pfizer Investigational Site

Lisbon, 1169-019, Portugal

Location

Pfizer Investigational Site

Lisbon, 1169-097, Portugal

Location

Pfizer Investigational Site

Lisbon, 1649-035, Portugal

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Pfizer Investigational Site

Porto, 4099-001, Portugal

Location

Pfizer Investigational Site

Cluj-Napoca, Cluj, 400006, Romania

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Moscow, 119331, Russia

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Saint Petersburg, 194100, Russia

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Belgrade, 11000, Serbia

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Bratislava, 83340, Slovakia

Location

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Ljubljana, 1000, Slovenia

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Pfizer Investigational Site

Myfair West, 2109, South Africa

Location

Pfizer Investigational Site

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Pfizer Investigational Site

Madrid, 28040, Spain

Location

Pfizer Investigational Site

Seville, 41013, Spain

Location

Pfizer Investigational Site

Kharkiv, 61000, Ukraine

Location

Pfizer Investigational Site

Kyiv, 01135, Ukraine

Location

Pfizer Investigational Site

Kyiv, 04050, Ukraine

Location

Pfizer Investigational Site

Kyiv, Ukraine

Location

Pfizer Investigational Site

Odesa, 65061, Ukraine

Location

Pfizer Investigational Site

Birmingham, B18 7QH, United Kingdom

Location

Pfizer Investigational Site

London, EC1V 2PD, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Glaucoma

Interventions

Timolol; Latanoprost

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 16, 2008
• Study Start: July 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 3, 2021
• Results First Posted: December 2, 2010

Record last verified: 2011-01

Locations

DE (2); PH (2); BE (1); SL (1); SE (1); ZA (1); CO (2); RU (2); PL (3); ES (3); PT (5); CZ (1); US (7); IN (3); IT (2); UA (5); GB (2); RO (1); FR (3)