A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01646151
• Collaborator: (none)
• Enrollment: 2,580
• Locations: 2
• Duration (Months): 11
• Patients Per Site: 1290
• Patients Per Site Per Month: 117.2

Study Details

Study Description

Brief Summary

An observational study comparing changing from an IOP-lowering treatment to a bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Visits and treatment are per normal clinical practice.

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

Study Design

• Study Type: Observational
• Actual Enrollment: 2580 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Bimatoprost Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.	Drug: Bimatoprost; Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.; Other Names: LUMIGAN® GANFORT®

Outcome Measures

Primary Outcome Measures

1. Intraocular Pressure (IOP) at Baseline [Baseline]

   IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.

2. IOP at Week 12 [Week 12]

   IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.

Secondary Outcome Measures

1. Physician Evaluation of IOP Lowering in the Study Eye(s) [Week 12]

   IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.

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

   Patient assessment of tolerability was 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 [Week 12]

   Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.

4. Physician Assessment of Patient Compliance Compared to Previous Therapy [Week 12]

   Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.

5. Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment [12 Weeks]

   Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No.

6. Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops [Week 12]

   Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Diagnosis of POAG or OHT

• Previous use of IOP-lowering medication

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Dresden		Germany
2		Amsterdam		Netherlands

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01646151
• Other Study ID Numbers: MAF/AGN/OPH/GLA/033
• First Posted: Jul 20, 2012
• Last Update Posted: Jun 13, 2014
• Last Verified: May 1, 2014

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

Study Results

Participant Flow

Arm/Group Title	Bimatoprost
Arm/Group Description	Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Period Title: Overall Study
STARTED	2580
COMPLETED	2410
NOT COMPLETED	170

Baseline Characteristics

Arm/Group Title	Bimatoprost
Arm/Group Description	Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Overall Participants	2580
Age, Customized (Number) [Number]
<18 years	0 0%
18 to 30 years	12 0.5%
31 to 40 years	20 0.8%
41 to 50 years	178 6.9%
51 to 60 years	403 15.6%
61 to 70 years	695 26.9%
71 to 80 years	883 34.2%
81 to 90 years	342 13.3%
>=91 years	19 0.7%
Missing	28 1.1%
Sex/Gender, Customized (Number) [Number]
Female	1454 56.4%
Male	1115 43.2%
Missing	11 0.4%

Outcome Measures

1. Primary Outcome

Title	Intraocular Pressure (IOP) at Baseline
Description	IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All patients with data for this outcome measure

Arm/Group Title	Bimatoprost
Arm/Group Description	Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Measure Participants	2099
Right Eye	20.51 (4.32)
Left Eye (n=2091)	20.65 (4.54)

2. Secondary Outcome

Title	Physician Evaluation of IOP Lowering in the Study Eye(s)
Description	IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All patients with data for this outcome measure

Arm/Group Title	Bimatoprost
Arm/Group Description	Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Measure Participants	2375
Measure Eyes	2671
IOP lower than target	622
Target IOP reached	1173
IOP decreased but target not reached	467
IOP increased	85
No change	119
Data Missing	205

3. Secondary Outcome

Title	Patient Assessment of Tolerability on a 4-Point Scale
Description	Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All patients with data for this outcome measure

Arm/Group Title	Bimatoprost
Arm/Group Description	Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Measure Participants	2347
Very Good	1127
Good	1070
Moderate	80
Poor	70

4. Secondary Outcome

Title	Physician Assessment of Tolerability on a 4-Point Scale
Description	Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All patients with data for this outcome measure

Arm/Group Title	Bimatoprost
Arm/Group Description	Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Measure Participants	2369
Very Good	1212
Good	1059
Moderate	74
Poor	24

5. Secondary Outcome

Title	Physician Assessment of Patient Compliance Compared to Previous Therapy
Description	Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All patients with data for this outcome measure

Arm/Group Title	Bimatoprost
Arm/Group Description	Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Measure Participants	2113
Better	875
Equal	1151
Worse	51
Not Applicable	36

6. Secondary Outcome

Title	Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment
Description	Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No.
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

All patients

Arm/Group Title	Bimatoprost
Arm/Group Description	Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Measure Participants	2580
Number [Percentage of Patients]	6.6

7. Secondary Outcome

Title	Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops
Description	Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All patients

Arm/Group Title	Bimatoprost
Arm/Group Description	Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Measure Participants	2580
Number [Percentage of Patients]	85.8

8. Primary Outcome

Title	IOP at Week 12
Description	IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All patients with data for this outcome measure

Arm/Group Title	Bimatoprost
Arm/Group Description	Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Measure Participants	2099
Right Eye	15.78 (2.85)
Left Eye (n=2091)	15.87 (3.19)

Adverse Events

Adverse Event Reporting Description	All enrolled patients were used to assess adverse events (AEs) and serious adverse events (SAEs).
Arm/Group Title	Bimatoprost
Arm/Group Description	Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
All Cause Mortality
	Bimatoprost
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Bimatoprost
	Affected / at Risk (%)	# Events
Total	0/2580 (0%)
Other (Not Including Serious) Adverse Events
	Bimatoprost
	Affected / at Risk (%)	# Events
Total	450/2580 (17.4%)
Eye disorders
Conjunctival Hyperaemia	292/2580 (11.3%)
Eye Irritation	158/2580 (6.1%)

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.