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A Study Demonstrating The Effect Of Latanoprost In Combination With Timolol, Latanoprost Alone And Timolol Alone On Eye Pressure In Open Angle Glaucoma Or Ocular Hypertension In Patients

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Aachen, , Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ocular Hypertension, Glaucoma, Open-Angle 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 (two
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.

- Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block.
(The routines for prescribing topical B-blocking agents will be followed.

- Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary
disease. (The routines for prescribing topical B-blocking agents will be followed).

- Pregnancy

- Women of childbearing potential who has not used adequate contraceptive methods during
the last three months.

- Inability to adhere to treatment/visit plan.

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

NCT00856622
Pfizer
Completed
A Study Demonstrating The Effect Of Latanoprost In Combination With Timolol, Latanoprost Alone And Timolol Alone On Eye Pressure In Open Angle Glaucoma Or Ocular Hypertension In Patients

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A Study Demonstrating The Effect Of Latanoprost In Combination With Timolol, Latanoprost Alone And Timolol Alone On Eye Pressure In Open Angle Glaucoma Or Ocular Hypertension In Patients
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.
The purpose of this study is to demonstrate that fixed combination of latanoprost and timolol (PhXA41) has better IOP lowering effect than the individual monotherapies.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Ocular Hypertension
  • Glaucoma
  • Open-Angle Glaucoma
  • Drug: i. Fixed combination of latanoprost 0.005% and timolol 0.5%
    one drop in the morning and placebo in the evening
    Other Name: xalacom, xalcom
  • Drug: timolol 0.5% ophthalmic solution
    one drop in the morning and evening
    Other Name: timoptic
  • Drug: latanoprost 0.005% ophthalmic solution
    placebo in the morning and latanoprost .005% in the evening
    Other Name: xalatan
  • Experimental: Fixed combination of latanoprost 0.005% and timolol 0.5%
    Intervention: Drug: i. Fixed combination of latanoprost 0.005% and timolol 0.5%
  • Active Comparator: timolol 0.5% ophthalmic solution
    one drop in the morning and evening
    Intervention: Drug: timolol 0.5% ophthalmic solution
  • Active Comparator: latanoprost 0.005% ophthalmic solution
    placebo in the morning and latanoprost .005% in the evening
    Intervention: Drug: latanoprost 0.005% ophthalmic solution
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
436
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 (two 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.
  • Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (The routines for prescribing topical B-blocking agents will be followed.
  • Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (The routines for prescribing topical B-blocking agents will be followed).
  • Pregnancy
  • Women of childbearing potential who has not used adequate contraceptive methods during the last three months.
  • 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
Germany
 
 
NCT00856622
96TIPG004
A6641005
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 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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