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

Viatris

Status and phase: Completed; Phase 3

Conditions: Open-angle Glaucoma; Glaucoma; Ocular Hypertension

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00856622

96TIPG004

A6641005

Details and patient eligibility

About

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.

Enrollment: 436 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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436 participants in 3 patient groups

Fixed combination of latanoprost 0.005% and timolol 0.5%

Experimental group

Treatment:

Drug: i. Fixed combination of latanoprost 0.005% and timolol 0.5%

timolol 0.5% ophthalmic solution

Active Comparator group

Description:

one drop in the morning and evening

Treatment:

Drug: timolol 0.5% ophthalmic solution

latanoprost 0.005% ophthalmic solution

Active Comparator group

Description:

placebo in the morning and latanoprost .005% in the evening

Treatment:

Drug: latanoprost 0.005% ophthalmic solution