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

NCT00856622

Last updated date
Study Location
Pfizer Investigational Site
Aachen, , , Germany
Contact
1-800-718-1021

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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.

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Ocular Hypertension, Glaucoma, Open-angle GlaucomaA 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 NCT00856622
  1. Aachen,
  2. Aalen,
  3. Ahaus,
  4. Alzey,
  5. Aschaffenburg,
  6. Bad Abbach,
  7. Berlin,
  8. Coesfeld,
  9. Dillingen,
  10. Eitorf,
  11. Erlangen,
  12. Essen,
  13. Freiburg,
  14. Freising,
  15. Fulda,
  16. Greifswald,
  17. Gummersbach,
  18. Hannover,
  19. Hirschaid,
  20. Iserlohn,
  21. Koblenz,
  22. Leonberg,
  23. Leverkusen,
  24. Mainz,
  25. Mainz,
  26. Mainz,
  27. Muenchen,
  28. Muenchen,
  29. Mülheim,
  30. Münster,
  31. Offenbach,
  32. Osnabrueck,
  33. Parsberg,
  34. Siegburg,
  35. Sulzbach,
  36. Trier,
  37. Weiden,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 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
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.
Brief Summary 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.
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
  • Ocular Hypertension
  • Glaucoma
  • Open-angle Glaucoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
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: March 5, 2009)
436
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1999
Actual Primary Completion Date June 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 (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.
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 Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00856622
Other Study ID Numbers  ICMJE 96TIPG004
A6641005
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 October 2018

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