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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00856622
First received: March 2, 2009
Last updated: June 3, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Ocular Hypertension
Glaucoma
Open-Angle Glaucoma
Drug: i. Fixed combination of latanoprost 0.005% and timolol 0.5%
Drug: timolol 0.5% ophthalmic solution
Drug: latanoprost 0.005% ophthalmic solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all treatments at Week 26 [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26 [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • To compare the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • To compare the proportion of patients reaching pre-specified (15, 18, and 21 mmHg) target diurnal IOPs between the treatment groups at Week 26 [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • To describe the IOP development from baseline to Week 26 for all treatment groups [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52 [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • To follow the safety variables throughout the study periods. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Enrollment: 436
Study Start Date: August 1997
Study Completion Date: June 1999
Primary Completion Date: June 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: xalatan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856622

Locations
Germany
Pfizer Investigational Site
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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00856622     History of Changes
Other Study ID Numbers: 96TIPG004, A6641005
Study First Received: March 2, 2009
Last Updated: June 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
open-angle glaucoma ocular hypertension glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Timolol
Latanoprost
Therapeutic Uses
Pharmacologic Actions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on September 16, 2014