An Observational Study of Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) Who Switched IOP-lowering Treatments

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735214
• Other study ID #: MAF/AGN/OPH/GLA/037
• Status: Completed
• 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
• 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:

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

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