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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01735214
Other study ID # MAF/AGN/OPH/GLA/037
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 7, 2013
Est. completion date April 10, 2014

Study information

Verified date April 2019
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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:

Study Design


Intervention

Drug:
Prostaglandin Analogue -Containing IOP-Lowering Therapy
Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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

Outcome

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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