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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01853085
• Collaborator: (none)
• Enrollment: 1,830
• Location: 1
• Actual Duration (Months): 11
• Patients Per Site Per Month: 166.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Primary Open Angle; Ocular Hypertension	Drug: Bimatoprost Ophthalmic Solution

Study Design

• Study Type: Observational
• Actual Enrollment: 1830 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Actual Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Patients with POAG or OHT 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.	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.; Other Names: Lumigan® UD

Outcome Measures

Primary Outcome Measures

1. Intraocular Pressure (IOP) in the Study Eye at Baseline [Baseline]

   IOP is a measurement of the fluid pressure inside the study eye.

2. IOP in the Study Eye at Week 12 [Week 12]

   IOP is a measurement of the fluid pressure inside the study eye.

Secondary Outcome Measures

1. Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale [Baseline, 12 Weeks]

   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.

2. Patient Assessment of Tolerability on a 4-Point Scale [12 Weeks]

   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.

3. Physician Assessment of Tolerability on a 4-Point Scale [12 Weeks]

   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.

4. Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment [12 Weeks]

   Patient discontinuation of treatment with Lumigan® UD prior to 12 weeks of treatment is assessed as Yes or No.

5. Number of Patients Who Continue Treatment [12 Weeks]

   Patient continuation of treatment with Lumigan® UD after the end of study participation is assessed as Yes or No.

6. Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale [12 Weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Wiesloch	Baden-Württemberg	Germany

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01853085
• Other Study ID Numbers: MAF/AGN/OPH/GLA/038
• First Posted: May 14, 2013
• Last Update Posted: Apr 19, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension; Bimatoprost; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
Period Title: Overall Study
STARTED	1830
COMPLETED	1595
NOT COMPLETED	235

Baseline Characteristics

Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
Overall Participants	1830
Age, Customized (Number) [Number]
<18 years	1 0.1%
18-30 years	9 0.5%
31-40 years	28 1.5%
41-50 years	130 7.1%
51-60 years	328 17.9%
61-70 years	509 27.8%
71-80 years	601 32.8%
81-90 years	158 8.6%
≥ 91 years	16 0.9%
Missing Data	50 2.7%
Sex/Gender, Customized (Number) [Number]
Female	1098 60%
Male	723 39.5%
Missing Data	9 0.5%

Outcome Measures

1. Primary Outcome

Title	Intraocular Pressure (IOP) in the Study Eye at Baseline
Description	IOP is a measurement of the fluid pressure inside the study eye.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All patients with data for this outcome measure

Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
Measure Participants	1672
Mean (Standard Deviation) [Millimeters of Mercury (mmHg)]	21.15 (3.43)

2. Secondary Outcome

Title	Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale
Description	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.
Time Frame	Baseline, 12 Weeks

Outcome Measure Data

Analysis Population Description

All patients with data for this outcome measure

Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
Measure Participants	1716
Better than Expected	649
As Expected	916
Worse than Expected	151

3. Secondary Outcome

Title	Patient Assessment of Tolerability on a 4-Point Scale
Description	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.
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

All patients with data for this outcome measure

Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
Measure Participants	1730
Very Good	913
Good	670
Moderate	73
Poor	74

4. Secondary Outcome

Title	Physician Assessment of Tolerability on a 4-Point Scale
Description	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.
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

All patients with data for this outcome measure

Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
Measure Participants	1746
Very Good	982
Good	648
Moderate	78
Poor	38

5. Secondary Outcome

Title	Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment
Description	Patient discontinuation of treatment with Lumigan® UD prior to 12 weeks of treatment is assessed as Yes or No.
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

All enrolled patients

Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
Measure Participants	1830
Number [Patients]	139

6. Secondary Outcome

Title	Number of Patients Who Continue Treatment
Description	Patient continuation of treatment with Lumigan® UD after the end of study participation is assessed as Yes or No.
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

All enrolled patients

Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
Measure Participants	1830
Number [Patients]	1501

7. Secondary Outcome

Title	Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale
Description	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.
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

All patients with data for this outcome measure

Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
Measure Participants	1675
Better	848
Equal	777
Worse	50

8. Primary Outcome

Title	IOP in the Study Eye at Week 12
Description	IOP is a measurement of the fluid pressure inside the study eye.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All patients with data for this outcome measure

Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
Measure Participants	1672
Mean (Standard Deviation) [mmHg]	16.38 (2.93)

Adverse Events

Time Frame	Adverse events (AEs) were collected for 12 weeks.
Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
All Cause Mortality
	Patients With POAG or OHT
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Patients With POAG or OHT
	Affected / at Risk (%)	# Events
Total	2/1830 (0.1%)
Eye disorders
Cataract Operation	1/1830 (0.1%)
General disorders
Death	1/1830 (0.1%)
Other (Not Including Serious) Adverse Events
	Patients With POAG or OHT
	Affected / at Risk (%)	# Events
Total	0/1830 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.