Clinical trial NCT00856622: 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
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Hypertension
Glaucoma
Open-angle Glaucoma
Keywords: open-angle glaucoma ocular hypertension glaucoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 436
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: To demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.
timeFrame: 6 months
Secondary outcomes:
measure: To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all treatments at Week 26
timeFrame: 6 Months
measure: To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26
timeFrame: 6 Months
measure: To compare the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups
timeFrame: 6 Months
measure: To compare the proportion of patients reaching pre-specified (15, 18, and 21 mmHg) target diurnal IOPs between the treatment groups at Week 26
timeFrame: 6 Months
measure: To describe the IOP development from baseline to Week 26 for all treatment groups
timeFrame: 6 Months
measure: 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
timeFrame: 6 Months
measure: To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52
timeFrame: 6 Months
measure: To follow the safety variables throughout the study periods.
timeFrame: 6 Months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Pfizer Investigational Site
city: Aalen
country: Germany
facility: Pfizer Investigational Site
city: Ahaus
country: Germany
facility: Pfizer Investigational Site
city: Alzey
country: Germany
facility: Pfizer Investigational Site
city: Aschaffenburg
country: Germany
facility: Pfizer Investigational Site
city: Bad Abbach
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Coesfeld
country: Germany
facility: Pfizer Investigational Site
city: Dillingen
country: Germany
facility: Pfizer Investigational Site
city: Eitorf
country: Germany
facility: Pfizer Investigational Site
city: Erlangen
country: Germany
facility: Pfizer Investigational Site
city: Essen
country: Germany
facility: Pfizer Investigational Site
city: Freiburg
country: Germany
facility: Pfizer Investigational Site
city: Freising
country: Germany
facility: Pfizer Investigational Site
city: Fulda
country: Germany
facility: Pfizer Investigational Site
city: Greifswald
country: Germany
facility: Pfizer Investigational Site
city: Gummersbach
country: Germany
facility: Pfizer Investigational Site
city: Hannover
country: Germany
facility: Pfizer Investigational Site
city: Hirschaid
country: Germany
facility: Pfizer Investigational Site
city: Iserlohn
country: Germany
facility: Pfizer Investigational Site
city: Koblenz
country: Germany
facility: Pfizer Investigational Site
city: Leonberg
country: Germany
facility: Pfizer Investigational Site
city: Leverkusen
country: Germany
facility: Pfizer Investigational Site
city: Mainz
country: Germany
facility: Pfizer Investigational Site
city: Mainz
country: Germany
facility: Pfizer Investigational Site
city: Mainz
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Mülheim
country: Germany
facility: Pfizer Investigational Site
city: Münster
country: Germany
facility: Pfizer Investigational Site
city: Offenbach
country: Germany
facility: Pfizer Investigational Site
city: Osnabrueck
country: Germany
facility: Pfizer Investigational Site
city: Parsberg
country: Germany
facility: Pfizer Investigational Site
city: Siegburg
country: Germany
facility: Pfizer Investigational Site
city: Sulzbach
country: Germany
facility: Pfizer Investigational Site
city: Trier
country: Germany
facility: Pfizer Investigational Site
city: Weiden
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: