Ocular Hypertension Clinical Trial
Verified date | April 2019 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study is a prospective, observational study of changing from any IOP-lowering treatment to a prostaglandin analogue-containing IOP-lowering medication for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The decision to change medications lies with the physician according to their standard practice.
Status | Completed |
Enrollment | 358 |
Est. completion date | April 10, 2014 |
Est. primary completion date | April 10, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT) - Previously prescribed any IOP-lowering therapy which has been stopped and a new prostaglandin analogue -containing IOP-lowering therapy started Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Allergan |
Turkey,
Tamçelik N, Izgi B, Temel A, Yildirim N, Okka M, Özcan A, Yüksel N, Elgin U, Altan Ç, Ozer B. Prospective, non-interventional, multicenter study of the intraocular pressure-lowering effects of prostaglandin analog/prostamide-containing therapies in previously treated patients with open-angle glaucoma or ocular hypertension. Clin Ophthalmol. 2017 Apr 19;11:723-731. doi: 10.2147/OPTH.S119963. eCollection 2017. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Intraocular Pressure (IOP) in the Right Eye | IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement. | Baseline, Week 12 | |
Primary | Change From Baseline in Intraocular Pressure (IOP) in the Left Eye | IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement. | Baseline, Week 12 | |
Secondary | Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale | The patient evaluated the tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported. | 12 Weeks | |
Secondary | Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale | The physician evaluated the patient's tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported. | 12 Weeks | |
Secondary | Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks | 12 Weeks | ||
Secondary | Percentage of Participants Who Continue the New Treatment After 12 Weeks | 12 Weeks | ||
Secondary | Physician Assessment of Adherence to New Treatment Using a 4-Point Scale | The physician assessed the participant's adherence to new treatment using the following scale: Not Applicable, Worse, Equal or Better. The percentage of participants in each category is reported. | 12 Weeks | |
Secondary | Physician Assessment of Efficacy Using a 5-Point Scale | The physician evaluated efficacy (IOP lowering) using a 5-Point Scale: IOP lower than target, Reached Target IOP, IOP decreased but target not reached, No change or IOP increased. The percentage of participants in each category is reported. | 12 Weeks | |
Secondary | Percentage of Participants Reaching Individual IOP Target After 12 Weeks | 12 Weeks |
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