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

• Status: Completed
• Trial end date: 1999-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Latanoprost; Timolol

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 (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.