A 6 Month Study Comparing Latanoprost With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00751127
First received: September 10, 2008
Last updated: March 24, 2011
Last verified: September 2008
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Purpose
PhXA41 is not inferior to timolol
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma Open Angle Glaucoma Ocular Hypertension |
Drug: PhXA41 Drug: timolol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A 6-month, Randomized, Double-masked Comparison of Latanoprost (PhXA41) With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension. A Multi-centre Study in the United States. |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment. [ Time Frame: 6 mos ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups. [ Time Frame: 6 mos ] [ Designated as safety issue: No ]
| Enrollment: | 268 |
| Study Start Date: | January 1993 |
| Study Completion Date: | February 1994 |
| Primary Completion Date: | February 1994 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Timolol |
Drug: timolol
One drop in the affected eye twice daily for six months.
|
| Experimental: PhXA41 |
Drug: PhXA41
One drop in the affected eye once daily for six months.
|
Eligibility| Ages Eligible for Study: | 40 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.
- Open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.)
- IOP of 22mmHg or higher obtained during the pre-study period.
Patients currently not treated or on single-drug treatment for the elevated IOP are eligible after a medication free period (wash-out) of:
- 3 weeks for B-adrenergic antagonists
- 2 weeks for adrenergic agonists
- 5 days for cholinergics and oral carbonic anhydrase inhibitors.
Exclusion Criteria:
- History of acute angle closure.
- Severe trauma at any time.
- Intraocular surgery or argon laser trabeculoplasty within 6 months.
- Current use of contact lenses.
- History of severe dry eye syndrome.
- Ocular inflammation/infection with three months of inclusion.
- Any condition preventing reliable applanation tonometry.
- Unacceptable finding at pre-study ocular examination as specified in the Case Report Forms.
- In Investigator regards monotherapy insufficient with respect to optic nerve head and/or visual field status.
- Treatment of elevated IOP with any topical B-adrenergic antagonist regularly for a period longer than 3 months and/or treatment at any time during 6 months prior to study start.
- Cardiac failure, sinus bradycardia, second and third degree of atrio-ventricular block.
- Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
- Having participated in any other clinical study within the last month.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751127
Locations
| United States, California | |
| Pfizer Investigational Site | |
| La Jolla, California, United States, 92093-0946 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90033 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Gainesville, Florida, United States, 32610 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States, 60612 | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States, 60611 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Louisville, Kentucky, United States, 40292 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Baltimore, Maryland, United States, 21209 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Ann Arbor, Michigan, United States | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Pfizer Investigational Site | |
| Omaha, Nebraska, United States, 68105 | |
| United States, New Jersey | |
| Pfizer Investigational Site | |
| River Edge, New Jersey, United States, 07661-1931 | |
| United States, New York | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10029 | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10003 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Portland, Oregon, United States, 97210-3049 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19107-5599 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Charleston, South Carolina, United States, 29425-0001 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Madison, Wisconsin, United States, 53705-3611 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided by Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00751127 History of Changes |
| Other Study ID Numbers: | 9200PG004 |
| Study First Received: | September 10, 2008 |
| Last Updated: | March 24, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
open angle glaucoma ocular hypertension |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle 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 May 19, 2013