To investigate the effectiveness of the newer IOP-lowering therapies, as prescribed in normal clinical practice, in larger patient numbers. Patients will be assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit...
Date First Received: July 14, 2008
Last Updated: July 15, 2008
Verified by: Allergan, July 2008
Clinical Trial Phase: N/A | Start Date: September 2004
Overall Status: Active, not recruiting
Estimated Enrollment: 1000
Brief Summary
Condition Keyword(s):
Intervention(s):
To investigate the effectiveness of the newer IOP-lowering therapies, as prescribed in normal clinical practice, in larger patient numbers. Patients will be assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.
Study Type: Observational
Study Design: Cohort, Prospective
Study Primary Completion Date: August 2009
Intervention(s) in this Clinical Trial
- Drug: bimatoprost 0.03%, latanoprost 0.005%, and travoprost 0.004%
- 1 drop in eye(s) every evening
Arms, Groups and Cohorts in this Clinical Trial
- : 1
- bimatoprost 0.03% latanoprost 0.005% travoprost 0.004%
Outcome Measures for this Clinical Trial
Primary Measures
- Effectiveness of IOP-lowering therapies as assessed by IOP measurements, VFD, and corneal thickness
- Time Frame: Assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit
Safety Issue?: No
- Time Frame: Assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit
Secondary Measures
- Quality of Life and Patient-Reported Outcomes
- Time Frame: Assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit
Safety Issue?: No
- Time Frame: Assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- A diagnosis of Primary Open-Angle Glaucoma or Ocular Hypertension newly diagnosed OR presenting with insufficiently controlled IOP on current medication (in the opinion of the treating physician)
- Patient is having both eyes treated
Exclusion Criteria:
- Contraindications per product labelling will apply.
- Patients with any ophthalmic co-morbidity with an influence on visual field deterioration or optic nerve head damage.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Allergan
Overall Clinical Trial Officials and Contacts
Medical Director Study Director Allergan
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00716742
Study ID Number: Pro2
ClinicalTrials.gov Identifier: NCT00716742
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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