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A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within the United Kingdom

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NCT00751049

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Aberdeen, Grampian, AB25 2ZD United Kingdom
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ocular Hypertension, Open Angle Glaucoma
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.

- 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
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.

NCT00751049
Pfizer
Completed
A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within the United Kingdom

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A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within the United Kingdom
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 PhXA41 for its non-inferiority compared with timolol in lowering intra-ocular pressure
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Ocular Hypertension
  • Open Angle Glaucoma
  • 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.
  • Experimental: PhXA41
    Intervention: Drug: PhXA41
  • Active Comparator: timolol
    Intervention: Drug: timolol
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.
 
Completed
294
December 1993
December 1993   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00751049
9200PG005
A6111129
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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