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

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

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

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma
• Intervention / Treatment: Drug: fixed combination latanoprost-timolol; Drug: latanoprost 0.005%; Drug: timolol 0.5%

• Study Type: Interventional
• Enrollment (Actual): 418
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Pfizer Investigational Site
    • Anaheim, California, United States, 92807
      • Pfizer Investigational Site
    • Sacramento, California, United States, 95823
      • Pfizer Investigational Site
    • Sacramento, California, United States, 95819
      • Pfizer Investigational Site
    • San Francisco, California, United States, 94115
      • Pfizer Investigational Site
  • Colorado
    • Boulder, Colorado, United States, 80304-3573
      • Pfizer Investigational Site
    • Denver, Colorado, United States, 80210
      • Pfizer Investigational Site
  • Florida
    • Largo, Florida, United States, 34640
      • Pfizer Investigational Site
    • Tampa, Florida, United States, 33613
      • Pfizer Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Pfizer Investigational Site
    • Atlanta, Georgia, United States, 30322
      • Pfizer Investigational Site
    • Atlanta, Georgia, United States, 30349
      • Pfizer Investigational Site
    • East Point, Georgia, United States, 30223
      • Pfizer Investigational Site
    • Griffin, Georgia, United States, 30223
      • Pfizer Investigational Site
    • Morrow, Georgia, United States, 30260
      • Pfizer Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Pfizer Investigational Site
    • Wheaton, Illinois, United States, 60187
      • Pfizer Investigational Site
  • Indiana
    • Elkhart, Indiana, United States, 46515
      • Pfizer Investigational Site
    • Mishawaka, Indiana, United States, 46545
      • Pfizer Investigational Site
    • South Bend, Indiana, United States, 46601
      • Pfizer Investigational Site
    • South Bend, Indiana, United States, 46617
      • Pfizer Investigational Site
  • Iowa
    • Iowa City, Iowa, United States, 52245
      • Pfizer Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Pfizer Investigational Site
    • Owings Mills, Maryland, United States, 21117
      • Pfizer Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Pfizer Investigational Site
  • Minnesota
    • Golden Valley, Minnesota, United States, 55422
      • Pfizer Investigational Site
    • Minneapolis, Minnesota, United States, 55421
      • Pfizer Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Pfizer Investigational Site
    • Kansas City, Missouri, United States, 64114
      • Pfizer Investigational Site
    • Warrensburg, Missouri, United States, 64093
      • Pfizer Investigational Site
  • New Hampshire
    • Concord, New Hampshire, United States, 03301
      • Pfizer Investigational Site
  • New Jersey
    • South Plainfield, New Jersey, United States, 07080
      • Pfizer Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Pfizer Investigational Site
    • Charlotte, North Carolina, United States, 28210
      • Pfizer Investigational Site
    • Charlotte, North Carolina, United States, 28260
      • Pfizer Investigational Site
    • Matthews, North Carolina, United States, 28105
      • Pfizer Investigational Site
    • Monroe, North Carolina, United States, 28112
      • Pfizer Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97210
      • Pfizer Investigational Site
    • Portland, Oregon, United States, 97201
      • Pfizer Investigational Site
  • Pennsylvania
    • Wyomissing, Pennsylvania, United States, 19610
      • Pfizer Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29412
      • Pfizer Investigational Site
    • Mount Pleasant, South Carolina, United States, 29464-3245
      • Pfizer Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Pfizer Investigational Site
  • Texas
    • Austin, Texas, United States, 78731-4941
      • Pfizer Investigational Site
    • Galveston, Texas, United States, 77555-1141
      • Pfizer Investigational Site
    • Houston, Texas, United States, 77030
      • Pfizer Investigational Site
  • Virginia
    • Charlottesville, Virginia, United States
      • Pfizer Investigational Site
    • Richmond, Virginia, United States, 23235
      • Pfizer Investigational Site
    • Richmond, Virginia, United States, 23219
      • Pfizer Investigational Site
  • Washington
    • Tacoma, Washington, United States, 98431
      • Pfizer Investigational Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Pfizer Investigational Site
    • Madison, Wisconsin, United States, 53715
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fixed combination of latanoprost 0.005% and timolol 0.5%	Drug: fixed combination latanoprost-timolol; one drop in the morning and placebo in the evening
Active Comparator: latanoprost 0.005%	Drug: latanoprost 0.005%; placebo in the morning and latanoprost .005% in the evening
Active Comparator: Timolol - 0.5%	Drug: timolol 0.5%; one drop in the morning and evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 objective: to demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26	6 months
To compared the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups	6 months
To describe the IOP development from baseline to Week 26 for all treatment groups	6 months
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
To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52	6 months
To follow the safety variables throughout the study periods.	6 months

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: July 1, 1997
• Primary Completion (Actual): June 1, 1999
• Study Completion (Actual): June 1, 1999

Study Registration Dates

• First Submitted: November 3, 2008
• First Submitted That Met QC Criteria: December 1, 2008
• First Posted (Estimate): December 2, 2008

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: ocular hypertension; glaucoma; timolol; latanoprost; Fixed combination latanoprost-timolol
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Timolol; Latanoprost
• Other Study ID Numbers: 96TIPG005; A6641006