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

Condition(s) targeted: Ocular Hypertension; Glaucoma; Open-Angle Glaucoma

Intervention: i. Fixed combination of latanoprost 0.005% and timolol 0.5% (Drug); timolol 0.5% ophthalmic solution (Drug); latanoprost 0.005% ophthalmic solution (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

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

Secondary outcome:

To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all treatments at Week 26

To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26

To compare the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups

To compare the proportion of patients reaching pre-specified (15, 18, and 21 mmHg) target diurnal IOPs between the treatment groups at Week 26

To describe the IOP development from baseline to Week 26 for all treatment groups

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

To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52

To follow the safety variables throughout the study periods.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Pfizer Investigational Site, Aachen, Germany

Pfizer Investigational Site, Aalen, Germany

Pfizer Investigational Site, Ahaus 48683, Germany

Pfizer Investigational Site, Alzey 55232, Germany

Pfizer Investigational Site, Aschaffenburg 63739, Germany

Pfizer Investigational Site, Bad Abbach 93077, Germany

Pfizer Investigational Site, Berlin 13088, Germany

Pfizer Investigational Site, Coesfeld 48653, Germany

Pfizer Investigational Site, Dillingen 89407, Germany

Pfizer Investigational Site, Eitorf 53783, Germany

Pfizer Investigational Site, Erlangen 91052, Germany

Pfizer Investigational Site, Essen 45147, Germany

Pfizer Investigational Site, Freiburg 79106, Germany

Pfizer Investigational Site, Freising 85354, Germany

Pfizer Investigational Site, Fulda, Germany

Pfizer Investigational Site, Greifswald 17489, Germany

Pfizer Investigational Site, Gummersbach 51643, Germany

Pfizer Investigational Site, Hannover, Germany

Pfizer Investigational Site, Hirschaid 96114, Germany

Pfizer Investigational Site, Iserlohn 58638, Germany

Pfizer Investigational Site, Koblenz 56068, Germany

Pfizer Investigational Site, Leonberg 71229, Germany

Pfizer Investigational Site, Leverkusen 51373, Germany

Pfizer Investigational Site, Mainz 55131, Germany

Pfizer Investigational Site, Mainz 55124, Germany

Pfizer Investigational Site, Mainz 55116, Germany

Pfizer Investigational Site, Muenchen 80336, Germany

Pfizer Investigational Site, Muenchen 81925, Germany

Pfizer Investigational Site, Mülheim 45481, Germany

Pfizer Investigational Site, Münster 48165, Germany

Pfizer Investigational Site, Offenbach 63065, Germany

Pfizer Investigational Site, Osnabrueck 49076, Germany

Pfizer Investigational Site, Parsberg 92331, Germany

Pfizer Investigational Site, Siegburg 53721, Germany

Pfizer Investigational Site, Sulzbach 66280, Germany

Pfizer Investigational Site, Trier 54290, Germany

Pfizer Investigational Site, Weiden 92637, Germany

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

Starting date: August 1997
Last updated: June 3, 2009