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

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856622
• Other study ID #: 96TIPG004
• Secondary ID: A6641005
• Status: Completed
• Phase: Phase 3
• Start date: August 1997
• Est. completion date: June 1999

Study information

• Verified date: October 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• 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 (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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-angle Glaucoma

Intervention

Drug:
• i. Fixed combination of latanoprost 0.005% and timolol 0.5%
one drop in the morning and placebo in the evening
• timolol 0.5% ophthalmic solution
one drop in the morning and evening
• latanoprost 0.005% ophthalmic solution
placebo in the morning and latanoprost .005% in the evening

Locations

Country	Name	City	State
Germany	Pfizer Investigational Site	Aachen
Germany	Pfizer Investigational Site	Aalen
Germany	Pfizer Investigational Site	Ahaus
Germany	Pfizer Investigational Site	Alzey
Germany	Pfizer Investigational Site	Aschaffenburg
Germany	Pfizer Investigational Site	Bad Abbach
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Coesfeld
Germany	Pfizer Investigational Site	Dillingen
Germany	Pfizer Investigational Site	Eitorf
Germany	Pfizer Investigational Site	Erlangen
Germany	Pfizer Investigational Site	Essen
Germany	Pfizer Investigational Site	Freiburg
Germany	Pfizer Investigational Site	Freising
Germany	Pfizer Investigational Site	Fulda
Germany	Pfizer Investigational Site	Greifswald
Germany	Pfizer Investigational Site	Gummersbach
Germany	Pfizer Investigational Site	Hannover
Germany	Pfizer Investigational Site	Hirschaid
Germany	Pfizer Investigational Site	Iserlohn
Germany	Pfizer Investigational Site	Koblenz
Germany	Pfizer Investigational Site	Leonberg
Germany	Pfizer Investigational Site	Leverkusen
Germany	Pfizer Investigational Site	Mainz
Germany	Pfizer Investigational Site	Mainz
Germany	Pfizer Investigational Site	Mainz
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Mülheim
Germany	Pfizer Investigational Site	Münster
Germany	Pfizer Investigational Site	Offenbach
Germany	Pfizer Investigational Site	Osnabrueck
Germany	Pfizer Investigational Site	Parsberg
Germany	Pfizer Investigational Site	Siegburg
Germany	Pfizer Investigational Site	Sulzbach
Germany	Pfizer Investigational Site	Trier
Germany	Pfizer Investigational Site	Weiden

Sponsors (1)

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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 treatments at Week 26		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 compare the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups		6 Months
Secondary	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
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.