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  • To compared the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]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
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
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Latanoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents

ClinicalTrials.gov processed this record on April 16, 2014