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Trial record 1 of 1 for:    NCT00856622
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00856622
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : October 16, 2018
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 2, 2009
First Posted Date  ICMJE March 6, 2009
Last Update Posted Date October 16, 2018
Study Start Date  ICMJE August 1997
Actual Primary Completion Date June 1999   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2009)
To demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies. [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
  • To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all treatments at Week 26 [ Time Frame: 6 Months ]
  • To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26 [ Time Frame: 6 Months ]
  • To compare the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups [ Time Frame: 6 Months ]
  • To compare the proportion of patients reaching pre-specified (15, 18, and 21 mmHg) target diurnal IOPs between the treatment groups at Week 26 [ Time Frame: 6 Months ]
  • To describe the IOP development from baseline to Week 26 for all treatment groups [ Time Frame: 6 Months ]
  • To compared the IOP reducing effect from baseline to Week 26 of the monotherapies with the IOP reducing effect from Week 26 to Week 52 of the fixed combination [ Time Frame: 6 Months ]
  • To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52 [ Time Frame: 6 Months ]
  • To follow the safety variables throughout the study periods. [ Time Frame: 6 Months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2009)
  • To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all treatments at Week 26 [ Time Frame: 6 Months ]
  • To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26 [ Time Frame: 6 Months ]
  • To compared the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups [ Time Frame: 6 Months ]
  • To compare the proportion of patients reaching pre-specified (15, 18, and 21 mmHg) target diurnal IOPs between the treatment groups at Week 26 [ Time Frame: 6 Months ]
  • To describe the IOP development from baseline to Week 26 for all treatment groups [ Time Frame: 6 Months ]
  • To compared the IOP reducing effect from baseline to Week 26 of the monotherapies with the IOP reducing effect from Week 26 to Week 52 of the fixed combination [ Time Frame: 6 Months ]
  • To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52 [ Time Frame: 6 Months ]
  • To follow the safety variables throughout the study periods. [ Time Frame: 6 Months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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