Clinical trial NCT00751062: A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within Scandinavia
Official title: A 6-month, Randomized, Double-masked Comparison of PhXA41 With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension. A Multi-centre Study in Scandinavia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open Angle Glaucoma
Ocular Hypertension
Keywords: open angle glaucoma ocular hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-11
Enrollment: 267
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 in reducing intra-ocular pressure


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.

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 demonstrate the IOP-reducing effect of PhXA41 administered in the morning is equivalent the effect of PhXA41 administered in the evening
timeFrame: 6 mos
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Pfizer Investigational Site
city: Vejle
country: Denmark
facility: Pfizer Investigational Site
city: Oulu
country: Finland
facility: Pfizer Investigational Site
city: Bergen
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Trondheim
country: Norway
facility: Pfizer Investigational Site
city: Gothenburg
country: Sweden
facility: Pfizer Investigational Site
city: Huddinge
country: Sweden
facility: Pfizer Investigational Site
city: Linkoping
country: Sweden
facility: Pfizer Investigational Site
city: Lund
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Umea
country: Sweden
facility: Pfizer Investigational Site
city: Uppsala
country: Sweden
facility: Pfizer Investigational Site
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.