A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00293761
First received: February 17, 2006
Last updated: March 2, 2012
Last verified: March 2012
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Purpose
The purpose of the study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension
| Condition | Intervention | Phase |
|---|---|---|
|
Open-angle Glaucoma Ocular Hypertension |
Drug: Travoprost, Investigational Drug: Travoprost (TRAVATAN) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
Drug Information available for:
Travoprost
U.S. FDA Resources
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Mean IOP
| Enrollment: | 109 |
| Study Start Date: | January 2006 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Travatan, Investigational |
Drug: Travoprost, Investigational
One drop in study eye once daily for 13 days
|
| Active Comparator: Travatan |
Drug: Travoprost (TRAVATAN)
One drop in study eye once daily for 13 days
Other Name: TRAVATAN
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients of either sex of any race diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Under age 18.
- Other protocol-defined exclusion criteria may apply.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT00293761 History of Changes |
| Other Study ID Numbers: | C-05-51 |
| Study First Received: | February 17, 2006 |
| Last Updated: | March 2, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Alcon Research:
|
open-angle glaucoma ocular hypertension |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Hypertension Ocular Hypertension Eye Diseases Vascular Diseases |
Cardiovascular Diseases Travoprost Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013