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

Phase 3

Completed

• Conditions: Open-angle Glaucoma; Ocular Hypertension; Glaucoma
• Interventions: Drug: latanoprost 0.005% ophthalmic solution; Drug: i. Fixed combination of latanoprost 0.005% and timolol 0.5%; Drug: timolol 0.5% ophthalmic solution

• Registration Number: NCT00856622
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-08
• Primary Completion: 1999-06
• Study Completion: 1999-06
• Study First Submitted: 2009-03-02
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-06
• Status Verified: 2018-10
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 436

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
latanoprost 0.005% ophthalmic solution	latanoprost 0.005% ophthalmic solution	placebo in the morning and latanoprost .005% in the evening
Fixed combination of latanoprost 0.005% and timolol 0.5%	i. Fixed combination of latanoprost 0.005% and timolol 0.5%	-
timolol 0.5% ophthalmic solution	timolol 0.5% ophthalmic solution	one drop in the morning and evening

Primary Outcome Measures

Name	Time	Method
To demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.	6 months

Secondary Outcome Measures

Name	Time	Method
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 examine, within treatment groups, the diurnal IOP reducing effect from baseline for all treatments at Week 26	6 Months
To follow the safety variables throughout the study periods.	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 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
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
To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52	6 Months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇩🇪 Weiden, Germany