Overview

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.