Status:
COMPLETED
A Study of Glaucoma or Ocular Hypertension in Patients Within the United States
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Ocular Hypertension
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 1999
Estimated Enrollment :
418 Patients enrolled
Trial Details
Trial ID
NCT00800267
Start Date
July 1 1997
End Date
June 1 1999
Last Update
February 18 2021
Active Locations (53)
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1
Pfizer Investigational Site
Anaheim, California, United States, 92801
2
Pfizer Investigational Site
Anaheim, California, United States, 92807
3
Pfizer Investigational Site
Sacramento, California, United States, 95819
4
Pfizer Investigational Site
Sacramento, California, United States, 95823