A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within the United Kingdom
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00751049
First received: September 10, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
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Purpose
Study PhXA41 for its non-inferiority compared with timolol in lowering intra-ocular pressure
| Condition | Intervention | Phase |
|---|---|---|
|
Ocular Hypertension Open Angle Glaucoma |
Drug: timolol Drug: PhXA41 |
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 PhXA41 With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension. A Multi-Centre Study in the United Kingdom |
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: | 294 |
| Study Start Date: | December 1992 |
| Study Completion Date: | December 1993 |
| Primary Completion Date: | December 1993 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PhXA41 |
Drug: PhXA41
One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.
|
| Active Comparator: timolol |
Drug: timolol
One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle
|
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: NCT00751049
Locations
| United Kingdom | |
| Pfizer Investigational Site | |
| Aberdeen, Grampian, United Kingdom, AB25 2ZD | |
| Pfizer Investigational Site | |
| Nottingham, Notts., United Kingdom, NG7 2UH | |
| Pfizer Investigational Site | |
| Bristol, United Kingdom, BS1 2LX | |
| Pfizer Investigational Site | |
| Cambridge, United Kingdom | |
| Pfizer Investigational Site | |
| Cardiff, United Kingdom, CF4 4XW | |
| Pfizer Investigational Site | |
| Dundee, United Kingdom, DD2 9SY | |
| Pfizer Investigational Site | |
| Liverpool, United Kingdom, L7 8XP | |
| Pfizer Investigational Site | |
| London, United Kingdom, NW3 2QG | |
| Pfizer Investigational Site | |
| London, United Kingdom | |
| Pfizer Investigational Site | |
| Manchester, United Kingdom | |
| Pfizer Investigational Site | |
| Paisley, United Kingdom | |
| Pfizer Investigational Site | |
| Sheffield, United Kingdom, S10 2JF | |
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: | NCT00751049 History of Changes |
| Other Study ID Numbers: | 9200PG005, A6111129 |
| Study First Received: | September 10, 2008 |
| Last Updated: | September 10, 2008 |
| 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 June 13, 2013