A Study of Glaucoma or Ocular Hypertension in Patients Within the United States

Viatris

Status and phase: Completed; Phase 3

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: fixed combination latanoprost-timolol; Drug: timolol 0.5%; Drug: latanoprost 0.005%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00800267

A6641006

96TIPG005

Details and patient eligibility

About

Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.

Enrollment: 418 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 (Ltwo 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.
• Patients with conditions in which treatment with B-blocking agents are contraindicated: cardiac failure, sinus bradycardia, second and third degree atrio-ventricular block.
• Patients with conditions in which treatment with B-blocking agents are contraindicated: bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
• 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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418 participants in 3 patient groups

Fixed combination of latanoprost 0.005% and timolol 0.5%

Experimental group

Treatment:

Drug: fixed combination latanoprost-timolol

latanoprost 0.005%

Active Comparator group

Treatment:

Drug: latanoprost 0.005%

Timolol - 0.5%

Active Comparator group

Treatment:

Drug: timolol 0.5%