A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01853085
• Other study ID #: MAF/AGN/OPH/GLA/038
• Status: Completed
• Start date: April 1, 2013
• Est. completion date: March 1, 2014

Study information

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

Clinical Trial Summary

The study will evaluate patients diagnosed with primary open angle glaucoma or ocular hypertension who are switched to Lumigan® UD monotherapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1830
• Est. completion date: March 1, 2014
• Est. primary completion date: March 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosed with primary open-angle glaucoma or ocular hypertension

• Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to Lumigan® UD for medical reasons

Exclusion Criteria:

Related Conditions & MeSH terms

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

Intervention

Drug:
• Bimatoprost Ophthalmic Solution
Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Pillunat LE, Eschstruth P, Häsemeyer S, Thelen U, Foja C, Leaback R, Pfennigsdorf S. Preservative-free bimatoprost 0.03% in patients with primary open-angle glaucoma or ocular hypertension in clinical practice. Clin Ophthalmol. 2016 Sep 12;10:1759-65. doi: 10.2147/OPTH.S103084. eCollection 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure (IOP) in the Study Eye at Baseline	IOP is a measurement of the fluid pressure inside the study eye.	Baseline
Primary	IOP in the Study Eye at Week 12	IOP is a measurement of the fluid pressure inside the study eye.	Week 12
Secondary	Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale	IOP is a measurement of the fluid pressure inside the eye. Physicians evaluate IOP change from baseline in the study eye as better than expected, as expected, and worse than expected. The numbers of patients in each category are presented.	Baseline, 12 Weeks
Secondary	Patient Assessment of Tolerability on a 4-Point Scale	Patient assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.	12 Weeks
Secondary	Physician Assessment of Tolerability on a 4-Point Scale	Physician assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.	12 Weeks
Secondary	Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment	Patient discontinuation of treatment with Lumigan® UD prior to 12 weeks of treatment is assessed as Yes or No.	12 Weeks
Secondary	Number of Patients Who Continue Treatment	Patient continuation of treatment with Lumigan® UD after the end of study participation is assessed as Yes or No.	12 Weeks
Secondary	Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale	Physician assessment of patient compliance compared to previous therapy is assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.	12 Weeks