A Study Demonstrating The Effect Of Latanoprost In Combination With Timolol, Latanoprost Alone And Timolol Alone On Eye Pressure In Open Angle Glaucoma Or Ocular Hypertension In Patients

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.

The purpose of this study is to demonstrate that fixed combination of latanoprost and timolol (PhXA41) has better IOP lowering effect than the individual monotherapies.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma; Open-angle Glaucoma
• Intervention / Treatment: Drug: i. Fixed combination of latanoprost 0.005% and timolol 0.5%; Drug: timolol 0.5% ophthalmic solution; Drug: latanoprost 0.005% ophthalmic solution

• Study Type: Interventional
• Enrollment (Actual): 436
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany
    • Pfizer Investigational Site
  • Aalen, Germany
    • Pfizer Investigational Site
  • Ahaus, Germany, 48683
    • Pfizer Investigational Site
  • Alzey, Germany, 55232
    • Pfizer Investigational Site
  • Aschaffenburg, Germany, 63739
    • Pfizer Investigational Site
  • Bad Abbach, Germany, 93077
    • Pfizer Investigational Site
  • Berlin, Germany, 13088
    • Pfizer Investigational Site
  • Coesfeld, Germany, 48653
    • Pfizer Investigational Site
  • Dillingen, Germany, 89407
    • Pfizer Investigational Site
  • Eitorf, Germany, 53783
    • Pfizer Investigational Site
  • Erlangen, Germany, 91052
    • Pfizer Investigational Site
  • Essen, Germany, 45147
    • Pfizer Investigational Site
  • Freiburg, Germany, 79106
    • Pfizer Investigational Site
  • Freising, Germany, 85354
    • Pfizer Investigational Site
  • Fulda, Germany
    • Pfizer Investigational Site
  • Greifswald, Germany, 17489
    • Pfizer Investigational Site
  • Gummersbach, Germany, 51643
    • Pfizer Investigational Site
  • Hannover, Germany
    • Pfizer Investigational Site
  • Hirschaid, Germany, 96114
    • Pfizer Investigational Site
  • Iserlohn, Germany, 58638
    • Pfizer Investigational Site
  • Koblenz, Germany, 56068
    • Pfizer Investigational Site
  • Leonberg, Germany, 71229
    • Pfizer Investigational Site
  • Leverkusen, Germany, 51373
    • Pfizer Investigational Site
  • Mainz, Germany, 55116
    • Pfizer Investigational Site
  • Mainz, Germany, 55124
    • Pfizer Investigational Site
  • Mainz, Germany, 55131
    • Pfizer Investigational Site
  • Muenchen, Germany, 80336
    • Pfizer Investigational Site
  • Muenchen, Germany, 81925
    • Pfizer Investigational Site
  • Mülheim, Germany, 45481
    • Pfizer Investigational Site
  • Münster, Germany, 48165
    • Pfizer Investigational Site
  • Offenbach, Germany, 63065
    • Pfizer Investigational Site
  • Osnabrueck, Germany, 49076
    • Pfizer Investigational Site
  • Parsberg, Germany, 92331
    • Pfizer Investigational Site
  • Siegburg, Germany, 53721
    • Pfizer Investigational Site
  • Sulzbach, Germany, 66280
    • Pfizer Investigational Site
  • Trier, Germany, 54290
    • Pfizer Investigational Site
  • Weiden, Germany, 92637
    • 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 (two 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.
• Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (The routines for prescribing topical B-blocking agents will be followed.
• Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (The routines for prescribing topical B-blocking agents will be followed).
• Pregnancy
• Women of childbearing potential who has not used adequate contraceptive methods during the last three months.
• 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
• 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: i. Fixed combination of latanoprost 0.005% and timolol 0.5%; one drop in the morning and placebo in the evening; Other Names: xalacom, xalcom
ACTIVE_COMPARATOR: timolol 0.5% ophthalmic solution; one drop in the morning and evening	Drug: timolol 0.5% ophthalmic solution; one drop in the morning and evening; Other Names: timoptic
ACTIVE_COMPARATOR: latanoprost 0.005% ophthalmic solution; placebo in the morning and latanoprost .005% in the evening	Drug: latanoprost 0.005% ophthalmic solution; placebo in the morning and latanoprost .005% in the evening; Other Names: xalatan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 treatments at Week 26	6 Months
To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26	6 Months
To compare the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups	6 Months
To compare the proportion of patients reaching pre-specified (15, 18, and 21 mmHg) target diurnal IOPs between the treatment groups at Week 26	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: August 1, 1997
• Primary Completion (ACTUAL): June 1, 1999
• Study Completion (ACTUAL): June 1, 1999

Study Registration Dates

• First Submitted: March 2, 2009
• First Submitted That Met QC Criteria: March 5, 2009
• First Posted (ESTIMATE): March 6, 2009

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: open-angle glaucoma ocular hypertension glaucoma
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; 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; Timolol; Ophthalmic Solutions; Pharmaceutical Solutions; Latanoprost
• Other Study ID Numbers: 96TIPG004; A6641005