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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00800267
First received: November 3, 2008
Last updated: March 5, 2009
Last verified: March 2009
  Purpose

Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.


Condition Intervention Phase
Ocular Hypertension
Glaucoma
Drug: latanoprost 0.005%
Drug: fixed combination latanoprost-timolol
Drug: timolol 0.5%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The differences from baseline in diurnal IOP reduction after six months of treatment will be tested between the fixed combination and the monotherapy groups. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Primary objective: to demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all effect from baseline between the monotherapies latanoprost and timolol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To compared the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To describe the IOP development from baseline to Week 26 for all treatment groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To follow the safety variables throughout the study periods. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 418
Study Start Date: July 1997
Study Completion Date: June 1999
Primary Completion Date: June 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fixed combination of latanoprost 0.005% and timolol 0.5% Drug: fixed combination latanoprost-timolol
one drop in the morning and placebo in the evening
Active Comparator: latanoprost 0.005% Drug: latanoprost 0.005%
placebo in the morning and latanoprost .005% in the evening
Active Comparator: Timolol - 0.5% Drug: timolol 0.5%
one drop in the morning and evening

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800267

  Show 53 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00800267     History of Changes
Other Study ID Numbers: 96TIPG005, A6641006
Study First Received: November 3, 2008
Last Updated: March 5, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
glaucoma
ocular hypertension
Fixed combination latanoprost-timolol
latanoprost
timolol

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Latanoprost
Timolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014