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

Last updated on November 14, 2019

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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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Descriptive Information
Brief Title  ICMJE A Study of Glaucoma or Ocular Hypertension in Patients Within the United States
Official Title  ICMJE 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
Brief SummarySafety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.
Detailed DescriptionNot 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
  • Ocular Hypertension
  • Glaucoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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%
Publications *Not Provided


*   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: December 1, 2008)
418
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1999
Actual Primary Completion DateJune 1999   (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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00800267
Other Study ID Numbers  ICMJE 96TIPG005
A6641006
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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