A Study of Glaucoma or Ocular Hypertension in Patients Within the United States

Glaucoma Clinical Trial

Official title:

A 6-month, Randomized, Double-masked Comparison of Fixed Combination of Latanoprost and Timolol With the Individual Components, Continuing Into a 6-month Open Label Safety Study of Fixed Combination in Patients With Glaucoma or Ocular Hypertension. A Multicenter Study in the United States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800267
• Other study ID #: 96TIPG005
• Secondary ID: A6641006
• Status: Completed
• Phase: Phase 3
• Start date: July 1997
• Est. completion date: June 1999

Study information

• Verified date: March 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: June 1999
• Est. primary completion date: June 1999
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.

• Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (Ltwo IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP greater than or equal to 30mmHg (two IOP determinations at pre-study separated by at least one hour).

Exclusion Criteria:

• History of acute angle closure or closed/barely open anterior chamber angle.

• Current use of contact lenses.

• Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.

• Ocular inflammation/infection occurring within three months prior to pre-study visit.

• Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.

• Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.

• Patients with conditions in which treatment with B-blocking agents are contraindicated: cardiac failure, sinus bradycardia, second and third degree atrio-ventricular block.

• Patients with conditions in which treatment with B-blocking agents are contraindicated: bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.

• Inability to adhere to treatment/visit plan.

• Have participated in any other clinical study within one month prior to pre-study visit.

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• latanoprost 0.005%
placebo in the morning and latanoprost .005% in the evening
• fixed combination latanoprost-timolol
one drop in the morning and placebo in the evening
• timolol 0.5%
one drop in the morning and evening

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Boulder	Colorado
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Charlottesville	Virginia
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Concord	New Hampshire
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	East Point	Georgia
United States	Pfizer Investigational Site	Elkhart	Indiana
United States	Pfizer Investigational Site	Galveston	Texas
United States	Pfizer Investigational Site	Golden Valley	Minnesota
United States	Pfizer Investigational Site	Griffin	Georgia
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Iowa City	Iowa
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Largo	Florida
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Madison	Wisconsin
United States	Pfizer Investigational Site	Madison	Wisconsin
United States	Pfizer Investigational Site	Matthews	North Carolina
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	Mishawaka	Indiana
United States	Pfizer Investigational Site	Monroe	North Carolina
United States	Pfizer Investigational Site	Morrow	Georgia
United States	Pfizer Investigational Site	Mount Pleasant	South Carolina
United States	Pfizer Investigational Site	Owings Mills	Maryland
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Sacramento	California
United States	Pfizer Investigational Site	Sacramento	California
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	South Bend	Indiana
United States	Pfizer Investigational Site	South Bend	Indiana
United States	Pfizer Investigational Site	South Plainfield	New Jersey
United States	Pfizer Investigational Site	Tacoma	Washington
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Warrensburg	Missouri
United States	Pfizer Investigational Site	Wheaton	Illinois
United States	Pfizer Investigational Site	Wyomissing	Pennsylvania

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The differences from baseline in diurnal IOP reduction after six months of treatment will be tested between the fixed combination and the monotherapy groups.		6 months
Primary	Primary objective: to demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.		6 months
Secondary	To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all effect from baseline between the monotherapies latanoprost and timolol		6 months
Secondary	To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26		6 months
Secondary	To compared the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups		6 months
Secondary	To describe the IOP development from baseline to Week 26 for all treatment groups		6 months
Secondary	To compared the IOP reducing effect from baseline to Week 26 of the monotherapies with the IOP reducing effect from Week 26 to Week 52 of the fixed combination		6 months
Secondary	To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52		6 months
Secondary	To follow the safety variables throughout the study periods.		6 months

External Links

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