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A Study of Glaucoma or Ocular Hypertension in Patients Within the United States

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anaheim, California, 92801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ocular Hypertension, Glaucoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ 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.

- Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (Ltwo
IOP determinations at pre-study separated by at least one hour) OR Patients without
IOP reducing therapy: IOP greater than or equal to 30mmHg (two IOP determinations at
pre-study separated by at least one hour).

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

- History of acute angle closure or closed/barely open anterior chamber angle.

- Current use of contact lenses.

- Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to
pre-study visit.

- Ocular inflammation/infection occurring within three months prior to pre-study visit.

- Hypersensitivity to benzalkonium chloride or to any other component of the study drug
solutions.

- Other abnormal ocular condition or symptom preventing the patient from entering the
study, according to the investigator's judgement.

- Patients with conditions in which treatment with B-blocking agents are
contraindicated: cardiac failure, sinus bradycardia, second and third degree
atrio-ventricular block.

- Patients with conditions in which treatment with B-blocking agents are
contraindicated: bronchial asthma, history of bronchial asthma or chronic obstructive
pulmonary disease.

- Inability to adhere to treatment/visit plan.

- Have participated in any other clinical study within one month prior to pre-study
visit.

NCT00800267
Pfizer
Completed
A Study of Glaucoma or Ocular Hypertension in Patients Within the United States

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A Study of Glaucoma or Ocular Hypertension in Patients Within the United States
A 6-Month, Randomized, Double-Masked Comparison of Fixed Combination of Latanoprost and Timolol With the Individual Components, Continuing Into a 6-Month Open Label Safety Study of Fixed Combination in Patients With Glaucoma or Ocular Hypertension. A Multicenter Study in the United States
Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Ocular Hypertension
  • Glaucoma
  • Drug: latanoprost 0.005%
    placebo in the morning and latanoprost .005% in the evening
  • Drug: fixed combination latanoprost-timolol
    one drop in the morning and placebo in the evening
  • Drug: timolol 0.5%
    one drop in the morning and evening
  • Experimental: Fixed combination of latanoprost 0.005% and timolol 0.5%
    Intervention: Drug: fixed combination latanoprost-timolol
  • Active Comparator: latanoprost 0.005%
    Intervention: Drug: latanoprost 0.005%
  • Active Comparator: Timolol - 0.5%
    Intervention: Drug: timolol 0.5%
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
418
June 1999
June 1999   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
  • Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (Ltwo IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP greater than or equal to 30mmHg (two IOP determinations at pre-study separated by at least one hour).

Exclusion Criteria:

  • History of acute angle closure or closed/barely open anterior chamber angle.
  • Current use of contact lenses.
  • Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.
  • Ocular inflammation/infection occurring within three months prior to pre-study visit.
  • Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.
  • Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.
  • Patients with conditions in which treatment with B-blocking agents are contraindicated: cardiac failure, sinus bradycardia, second and third degree atrio-ventricular block.
  • Patients with conditions in which treatment with B-blocking agents are contraindicated: bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
  • Inability to adhere to treatment/visit plan.
  • Have participated in any other clinical study within one month prior to pre-study visit.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00800267
96TIPG005
A6641006
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2009

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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