Efficacy And Safety Of Xalatan Compared To Usual Care In Patients With Open Angle Glaucoma Or Ocular Hypertension.
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00140062
First received: August 29, 2005
Last updated: April 4, 2008
Last verified: April 2008
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Purpose
The primary purpose is to compare the intraocular pressure reducing effect of Xalatan with that of usual care over 36 months. Safety and health care utilization will be evaluated.
| Condition | Intervention | Phase |
|---|---|---|
|
Ocular Hypertension Glaucoma, Open-Angle |
Drug: latanoprost 0.005% (Xalatan) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Post-Marketing Efficacy And Safety Study Of Xalatan Compared With "Usual Care" Over 36 Months In Patients With Primary Open-Angle Glaucoma, Exfoliative Glaucoma Or Ocular Hypertension |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
Drug Information available for:
Latanoprost
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Time to treatment failure (change or addition of ocular hypertensive medical treatment, ocular surgery or laser trabeculoplasty) of latanoprost monotherapy or usual care over 36 months.
Secondary Outcome Measures:
- Safety and the health care utilization in the two treatment groups over 36 months.
| Estimated Enrollment: | 329 |
| Study Start Date: | February 2002 |
| Estimated Study Completion Date: | April 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Unilateral or bilateral open-angle glaucoma, exfoliative glaucoma, pigmentary glaucoma or ocular hypertension
- IOP of > 21 mm Hg on current treatment
Exclusion Criteria:
- Any previous or current treatment with latanoprost or other prostaglandin analogues
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00140062
Locations
| Finland | |
| Pfizer Investigational Site | |
| Helsinki, Finland, 00700 | |
| Pfizer Investigational Site | |
| Helsinki, Finland, 00100 | |
| Pfizer Investigational Site | |
| Kuopio, Finland, 70100 | |
| Pfizer Investigational Site | |
| Lahti, Finland, 15110 | |
| Pfizer Investigational Site | |
| Rovaniemi, Finland, 96200 | |
| Pfizer Investigational Site | |
| Seinajoki, Finland, 60100 | |
| Pfizer Investigational Site | |
| Tammisaari, Finland | |
| Pfizer Investigational Site | |
| Tampere, Finland, 33100 | |
| Pfizer Investigational Site | |
| Turku, Finland, 20100 | |
| Sweden | |
| Pfizer Investigational Site | |
| Jönköping, Sweden, 551 85 | |
| Pfizer Investigational Site | |
| Karlstad, Sweden, 652 20 | |
| Pfizer Investigational Site | |
| Kristianstad, Sweden, 291 31 | |
| Pfizer Investigational Site | |
| Linkoping, Sweden | |
| Pfizer Investigational Site | |
| Ludvika, Sweden, 771 81 | |
| Pfizer Investigational Site | |
| Molndal, Sweden | |
| Pfizer Investigational Site | |
| Nacka, Sweden, 131 83 | |
| Pfizer Investigational Site | |
| Norrkoping, Sweden, 601 82 | |
| Pfizer Investigational Site | |
| Norrkoping, Sweden, 602 36 | |
| Pfizer Investigational Site | |
| Nyköping, Sweden | |
| Pfizer Investigational Site | |
| Orebro, Sweden, 70361 | |
| Pfizer Investigational Site | |
| Seinajoki, Sweden, 151 72 | |
| Pfizer Investigational Site | |
| Stockholm, Sweden | |
| Pfizer Investigational Site | |
| Stockholm, Sweden, 113 22 | |
| Pfizer Investigational Site | |
| Sundsvall, Sweden, 851 86 | |
| Pfizer Investigational Site | |
| Täby, Sweden, 183 34 | |
| Pfizer Investigational Site | |
| Uppsala, Sweden | |
| Pfizer Investigational Site | |
| Uppsala, Sweden, 751 85 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00140062 History of Changes |
| Other Study ID Numbers: | 912-OPT-0091-156 |
| Study First Received: | August 29, 2005 |
| Last Updated: | April 4, 2008 |
| Health Authority: | Sweden: Medical Products Agency |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Hypertension Ocular Hypertension Eye Diseases Vascular Diseases |
Cardiovascular Diseases Latanoprost Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013