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

Completed · Phase 3 · Has a placebo group

Conditions studied: Ocular Hypertension, Glaucoma

In brief

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

Key facts

Study ID

NCT00800267

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

418

Starts

1997-07-01

Expected to finish

1999-06-01

Last updated by the study team

2021-02-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Anaheim, California, United States
• Pfizer Investigational Site — Sacramento, California, United States
• Pfizer Investigational Site — Sacramento, California, United States
• Pfizer Investigational Site — San Francisco, California, United States
• Pfizer Investigational Site — Boulder, Colorado, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Largo, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — East Point, Georgia, United States
• Pfizer Investigational Site — Griffin, Georgia, United States
• Pfizer Investigational Site — Morrow, Georgia, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Wheaton, Illinois, United States
• Pfizer Investigational Site — Elkhart, Indiana, United States
• Pfizer Investigational Site — Mishawaka, Indiana, United States
• Pfizer Investigational Site — South Bend, Indiana, United States
• Pfizer Investigational Site — South Bend, Indiana, United States
• Pfizer Investigational Site — Iowa City, Iowa, United States
• Pfizer Investigational Site — Louisville, Kentucky, United States
• Pfizer Investigational Site — Baltimore, Maryland, United States
• Pfizer Investigational Site — Owings Mills, Maryland, United States
• Pfizer Investigational Site — Anaheim, California, United States

Full record on ClinicalTrials.gov

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