Clinical trial NCT00751049: A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within the United Kingdom
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 the United Kingdom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Hypertension
Open Angle Glaucoma
Keywords: open angle glaucoma ocular hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-11
Enrollment: 294
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: Study PhXA41 for its non-inferiority compared with timolol in lowering 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.
* 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: Aberdeen
country: United Kingdom
facility: Pfizer Investigational Site
state: Grampian
city: Nottingham
country: United Kingdom
facility: Pfizer Investigational Site
state: Notts.
city: Bristol
country: United Kingdom
facility: Pfizer Investigational Site
city: Cambridge
country: United Kingdom
facility: Pfizer Investigational Site
city: Cardiff
country: United Kingdom
facility: Pfizer Investigational Site
city: Dundee
country: United Kingdom
facility: Pfizer Investigational Site
city: Liverpool
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
city: Paisley
country: United Kingdom
facility: Pfizer Investigational Site
city: Sheffield
country: United Kingdom
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.