Status:
COMPLETED
A 6 Month Study Comparing Latanoprost With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension
Lead Sponsor:
Pfizer
Conditions:
Glaucoma
Open Angle Glaucoma
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
PhXA41 is not inferior to timolol
Eligibility Criteria
Inclusion
- Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
- Open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.)
- IOP of 22mmHg or higher obtained during the pre-study period.
- Patients currently not treated or on single-drug treatment for the elevated IOP are eligible after a medication free period (wash-out) of:
- 3 weeks for B-adrenergic antagonists
- 2 weeks for adrenergic agonists
- 5 days for cholinergics and oral carbonic anhydrase inhibitors.
Exclusion
- History of acute angle closure.
- Severe trauma at any time.
- Intraocular surgery or argon laser trabeculoplasty within 6 months.
- Current use of contact lenses.
- History of severe dry eye syndrome.
- Ocular inflammation/infection with three months of inclusion.
- Any condition preventing reliable applanation tonometry.
- Unacceptable finding at pre-study ocular examination as specified in the Case Report Forms.
- In Investigator regards monotherapy insufficient with respect to optic nerve head and/or visual field status.
- Treatment of elevated IOP with any topical B-adrenergic antagonist regularly for a period longer than 3 months and/or treatment at any time during 6 months prior to study start.
- Cardiac failure, sinus bradycardia, second and third degree of atrio-ventricular block.
- Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
- Having participated in any other clinical study within the last month.
Key Trial Info
Start Date :
January 1 1993
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 1994
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT00751127
Start Date
January 1 1993
End Date
February 1 1994
Last Update
March 25 2011
Active Locations (17)
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1
Pfizer Investigational Site
La Jolla, California, United States, 92093-0946
2
Pfizer Investigational Site
Los Angeles, California, United States, 90033
3
Pfizer Investigational Site
Gainesville, Florida, United States, 32610
4
Pfizer Investigational Site
Chicago, Illinois, United States, 60611