A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within Scandinavia

NCT00751062

Last updated date
Study Location
Pfizer Investigational Site
Hellerup, , , Denmark
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Open Angle Glaucoma, Ocular Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within Scandinavia
Official Title  ICMJE 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
Brief Summary PhXA41 is not inferior to timolol in reducing intra-ocular pressure
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Open Angle Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: timolol
    One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.
  • Drug: PhXA41
    One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle
Study Arms  ICMJE
  • Active Comparator: Timolol
    Intervention: Drug: timolol
  • Experimental: PhXA41
    Intervention: Drug: PhXA41
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2008)
267
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1993
Actual Primary Completion Date December 1993   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Finland,   Norway,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00751062
Other Study ID Numbers  ICMJE 9200PG006
A6111130
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP