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
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00856622
First received: March 2, 2009
Last updated: June 3, 2009
Last verified: June 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ocular Hypertension Glaucoma Open-Angle Glaucoma |
Drug: i. Fixed combination of latanoprost 0.005% and timolol 0.5% Drug: timolol 0.5% ophthalmic solution Drug: latanoprost 0.005% ophthalmic solution |
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. |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 treatments at Week 26 [ 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- To compare the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
- 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 ] [ 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: | 436 |
| Study Start Date: | August 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: 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
|
|
Active Comparator: timolol 0.5% ophthalmic solution
one drop in the morning and evening
|
Drug: timolol 0.5% ophthalmic solution
one drop in the morning and evening
Other Name: timoptic
|
|
Active Comparator: latanoprost 0.005% ophthalmic solution
placebo in the morning and latanoprost .005% in the evening
|
Drug: latanoprost 0.005% ophthalmic solution
placebo in the morning and latanoprost .005% in the evening
Other Name: xalatan
|
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 (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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856622
Locations
| Germany | |
| Pfizer Investigational Site | |
| Aachen, Germany | |
| Pfizer Investigational Site | |
| Aalen, Germany | |
| Pfizer Investigational Site | |
| Ahaus, Germany, 48683 | |
| Pfizer Investigational Site | |
| Alzey, Germany, 55232 | |
| Pfizer Investigational Site | |
| Aschaffenburg, Germany, 63739 | |
| Pfizer Investigational Site | |
| Bad Abbach, Germany, 93077 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 13088 | |
| Pfizer Investigational Site | |
| Coesfeld, Germany, 48653 | |
| Pfizer Investigational Site | |
| Dillingen, Germany, 89407 | |
| Pfizer Investigational Site | |
| Eitorf, Germany, 53783 | |
| Pfizer Investigational Site | |
| Erlangen, Germany, 91052 | |
| Pfizer Investigational Site | |
| Essen, Germany, 45147 | |
| Pfizer Investigational Site | |
| Freiburg, Germany, 79106 | |
| Pfizer Investigational Site | |
| Freising, Germany, 85354 | |
| Pfizer Investigational Site | |
| Fulda, Germany | |
| Pfizer Investigational Site | |
| Greifswald, Germany, 17489 | |
| Pfizer Investigational Site | |
| Gummersbach, Germany, 51643 | |
| Pfizer Investigational Site | |
| Hannover, Germany | |
| Pfizer Investigational Site | |
| Hirschaid, Germany, 96114 | |
| Pfizer Investigational Site | |
| Iserlohn, Germany, 58638 | |
| Pfizer Investigational Site | |
| Koblenz, Germany, 56068 | |
| Pfizer Investigational Site | |
| Leonberg, Germany, 71229 | |
| Pfizer Investigational Site | |
| Leverkusen, Germany, 51373 | |
| Pfizer Investigational Site | |
| Mainz, Germany, 55116 | |
| Pfizer Investigational Site | |
| Mainz, Germany, 55124 | |
| Pfizer Investigational Site | |
| Mainz, Germany, 55131 | |
| Pfizer Investigational Site | |
| Muenchen, Germany, 80336 | |
| Pfizer Investigational Site | |
| Muenchen, Germany, 81925 | |
| Pfizer Investigational Site | |
| Mülheim, Germany, 45481 | |
| Pfizer Investigational Site | |
| Münster, Germany, 48165 | |
| Pfizer Investigational Site | |
| Offenbach, Germany, 63065 | |
| Pfizer Investigational Site | |
| Osnabrueck, Germany, 49076 | |
| Pfizer Investigational Site | |
| Parsberg, Germany, 92331 | |
| Pfizer Investigational Site | |
| Siegburg, Germany, 53721 | |
| Pfizer Investigational Site | |
| Sulzbach, Germany, 66280 | |
| Pfizer Investigational Site | |
| Trier, Germany, 54290 | |
| Pfizer Investigational Site | |
| Weiden, Germany, 92637 | |
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: | NCT00856622 History of Changes |
| Other Study ID Numbers: | 96TIPG004, A6641005 |
| Study First Received: | March 2, 2009 |
| Last Updated: | June 3, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
open-angle glaucoma ocular hypertension glaucoma |
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 17, 2013