Trial Outcomes & Findings for A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons (NCT NCT01853085)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

1830 participants

Primary outcome timeframe

Baseline

Results posted on

2019-04-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	1830
Overall Study COMPLETED	1595
Overall Study NOT COMPLETED	235

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With POAG or OHT n=1830 Participants 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.
Age, Customized <18 years	1 Participants n=5 Participants
Age, Customized 18-30 years	9 Participants n=5 Participants
Age, Customized 31-40 years	28 Participants n=5 Participants
Age, Customized 41-50 years	130 Participants n=5 Participants
Age, Customized 51-60 years	328 Participants n=5 Participants
Age, Customized 61-70 years	509 Participants n=5 Participants
Age, Customized 71-80 years	601 Participants n=5 Participants
Age, Customized 81-90 years	158 Participants n=5 Participants
Age, Customized ≥ 91 years	16 Participants n=5 Participants
Age, Customized Missing Data	50 Participants n=5 Participants
Sex/Gender, Customized Female	1098 Participants n=5 Participants
Sex/Gender, Customized Male	723 Participants n=5 Participants
Sex/Gender, Customized Missing Data	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: All patients with data for this outcome measure

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

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=1672 Participants 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.
Intraocular Pressure (IOP) in the Study Eye at Baseline	21.15 Millimeters of Mercury (mmHg) Standard Deviation 3.43

PRIMARY outcome

Timeframe: Week 12

Population: All patients with data for this outcome measure

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

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=1672 Participants 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.
IOP in the Study Eye at Week 12	16.38 mmHg Standard Deviation 2.93

SECONDARY outcome

Timeframe: Baseline, 12 Weeks

Population: All patients with data for this outcome measure

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.

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=1716 Participants 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.
Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale Better than Expected	649 Patients
Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale As Expected	916 Patients
Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale Worse than Expected	151 Patients

SECONDARY outcome

Timeframe: 12 Weeks

Population: All patients with data for this outcome measure

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.

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=1730 Participants 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.
Patient Assessment of Tolerability on a 4-Point Scale Very Good	913 Patients
Patient Assessment of Tolerability on a 4-Point Scale Good	670 Patients
Patient Assessment of Tolerability on a 4-Point Scale Moderate	73 Patients
Patient Assessment of Tolerability on a 4-Point Scale Poor	74 Patients

SECONDARY outcome

Timeframe: 12 Weeks

Population: All patients with data for this outcome measure

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.

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=1746 Participants 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.
Physician Assessment of Tolerability on a 4-Point Scale Very Good	982 Patients
Physician Assessment of Tolerability on a 4-Point Scale Good	648 Patients
Physician Assessment of Tolerability on a 4-Point Scale Moderate	78 Patients
Physician Assessment of Tolerability on a 4-Point Scale Poor	38 Patients

SECONDARY outcome

Timeframe: 12 Weeks

Population: All enrolled patients

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

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=1830 Participants 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.
Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment	139 Patients

SECONDARY outcome

Timeframe: 12 Weeks

Population: All enrolled patients

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

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=1830 Participants 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.
Number of Patients Who Continue Treatment	1501 Patients

SECONDARY outcome

Timeframe: 12 Weeks

Population: All patients with data for this outcome measure

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.

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=1675 Participants 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.
Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale Worse	50 Patients
Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale Better	848 Patients
Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale Equal	777 Patients

Adverse Events

Patients With POAG or OHT

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patients With POAG or OHT n=1830 participants at risk 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.
Eye disorders Cataract Operation	0.05% 1/1830 • Adverse events (AEs) were collected for 12 weeks.
General disorders Death	0.05% 1/1830 • Adverse events (AEs) were collected for 12 weeks.

Other adverse events

Adverse event data not reported

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER