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

NCT00856622 | Completed Phase 3

• 2 other identifiers: 96TIPG004A6641005
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 37

Brief Summary

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.

Conditions

Ocular Hypertension; Glaucoma; Open-angle Glaucoma

Keywords

open-angle glaucoma ocular hypertension glaucoma

Outcome Measures

Primary Outcomes (1)

• To demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.

  6 months

Secondary Outcomes (8)

• 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• To compare the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups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

Study Arms (3)

Fixed combination of latanoprost 0.005% and timolol 0.5%

EXPERIMENTAL

Drug: i. Fixed combination of latanoprost 0.005% and timolol 0.5%

timolol 0.5% ophthalmic solution

ACTIVE COMPARATOR

one drop in the morning and evening

Drug: timolol 0.5% ophthalmic solution

latanoprost 0.005% ophthalmic solution

ACTIVE COMPARATOR

placebo in the morning and latanoprost .005% in the evening

Drug: latanoprost 0.005% ophthalmic solution

Interventions

i. Fixed combination of latanoprost 0.005% and timolol 0.5% DRUG

one drop in the morning and placebo in the evening

Also known as: xalacom, xalcom

Fixed combination of latanoprost 0.005% and timolol 0.5%

timolol 0.5% ophthalmic solution DRUG

one drop in the morning and evening

Also known as: timoptic

timolol 0.5% ophthalmic solution

latanoprost 0.005% ophthalmic solution DRUG

placebo in the morning and latanoprost .005% in the evening

Also known as: xalatan

latanoprost 0.005% ophthalmic solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (37)

Pfizer Investigational Site

Aachen, Germany

Location

Pfizer Investigational Site

Aalen, Germany

Location

Pfizer Investigational Site

Ahaus, 48683, Germany

Location

Pfizer Investigational Site

Alzey, 55232, Germany

Location

Pfizer Investigational Site

Aschaffenburg, 63739, Germany

Location

Pfizer Investigational Site

Bad Abbach, 93077, Germany

Location

Pfizer Investigational Site

Berlin, 13088, Germany

Location

Pfizer Investigational Site

Coesfeld, 48653, Germany

Location

Pfizer Investigational Site

Dillingen, 89407, Germany

Location

Pfizer Investigational Site

Eitorf, 53783, Germany

Location

Pfizer Investigational Site

Erlangen, 91052, Germany

Location

Pfizer Investigational Site

Essen, 45147, Germany

Location

Pfizer Investigational Site

Freiburg im Breisgau, 79106, Germany

Location

Pfizer Investigational Site

Freising, 85354, Germany

Location

Pfizer Investigational Site

Fulda, Germany

Location

Pfizer Investigational Site

Greifswald, 17489, Germany

Location

Pfizer Investigational Site

Gummersbach, 51643, Germany

Location

Pfizer Investigational Site

Hanover, Germany

Location

Pfizer Investigational Site

Hirschaid, 96114, Germany

Location

Pfizer Investigational Site

Iserlohn, 58638, Germany

Location

Pfizer Investigational Site

Koblenz, 56068, Germany

Location

Pfizer Investigational Site

Leonberg, 71229, Germany

Location

Pfizer Investigational Site

Leverkusen, 51373, Germany

Location

Pfizer Investigational Site

Mainz, 55116, Germany

Location

Pfizer Investigational Site

Mainz, 55124, Germany

Location

Pfizer Investigational Site

Mainz, 55131, Germany

Location

Pfizer Investigational Site

Mülheim, 45481, Germany

Location

Pfizer Investigational Site

München, 80336, Germany

Location

Pfizer Investigational Site

München, 81925, Germany

Location

Pfizer Investigational Site

Münster, 48165, Germany

Location

Pfizer Investigational Site

Offenbach, 63065, Germany

Location

Pfizer Investigational Site

Osnabrück, 49076, Germany

Location

Pfizer Investigational Site

Parsberg, 92331, Germany

Location

Pfizer Investigational Site

Siegburg, 53721, Germany

Location

Pfizer Investigational Site

Sulzbach, 66280, Germany

Location

Pfizer Investigational Site

Trier, 54290, Germany

Location

Pfizer Investigational Site

Weiden, 92637, Germany

Location

Related Links

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

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle

Interventions

Xalacom; Timolol; Ophthalmic Solutions; Latanoprost

Condition Hierarchy (Ancestors)

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; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 2, 2009
• First Posted: March 6, 2009
• Study Start: August 1, 1997
• Primary Completion: June 1, 1999
• Study Completion: June 1, 1999
• Last Updated: February 21, 2021

Record last verified: 2018-10

Locations

DE (37)