Clinical trial NCT00751127: A 6 Month Study Comparing Latanoprost With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension
Official title: A 6-month, Randomized, Double-masked Comparison of Latanoprost (PhXA41) With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension. A Multi-centre Study in the United States.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Open Angle Glaucoma
Ocular Hypertension
Keywords: open angle glaucoma
ocular hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-11
Enrollment: 268
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PhXA41 is not inferior to timolol


Eligibility criteria: Inclusion Criteria:

* 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:

  1. 3 weeks for B-adrenergic antagonists
  2. 2 weeks for adrenergic agonists
  3. 5 days for cholinergics and oral carbonic anhydrase inhibitors.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment.
timeFrame: 6 mos
Secondary outcomes:
measure: to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups.
timeFrame: 6 mos
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: River Edge
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Varma R, Hwang LJ, Grunden JW, Bean GW, Sultan MB. Assessing the efficacy of latanoprost vs timolol using an alternate efficacy parameter: the intervisit intraocular pressure range. Am J Ophthalmol. 2009 Aug;148(2):221-6. doi: 10.1016/j.ajo.2009.02.035. Epub 2009 May 9.