Trial Outcomes & Findings for A Study of Lumigan® 0.01% in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) (NCT NCT01589510)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

419 participants

Primary outcome timeframe

Baseline

Results posted on

2014-06-13

Participant Flow

Participant milestones

Participant milestones
Measure	Lumigan® 0.01% Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
Overall Study STARTED	419
Overall Study COMPLETED	386
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Lumigan® 0.01% in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lumigan® 0.01% n=419 Participants Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
Age, Customized <18 years	0 Participants n=5 Participants
Age, Customized 18 to 30 years	1 Participants n=5 Participants
Age, Customized 31 to 40 years	7 Participants n=5 Participants
Age, Customized 41 to 50 years	33 Participants n=5 Participants
Age, Customized 51 to 60 years	66 Participants n=5 Participants
Age, Customized 61 to 70 years	137 Participants n=5 Participants
Age, Customized 71 to 80 years	116 Participants n=5 Participants
Age, Customized 81 to 90 years	51 Participants n=5 Participants
Age, Customized >=91 years	4 Participants n=5 Participants
Age, Customized Missing	4 Participants n=5 Participants
Sex/Gender, Customized Female	232 Participants n=5 Participants
Sex/Gender, Customized Male	183 Participants n=5 Participants
Sex/Gender, Customized Missing	4 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 eye. IOP was measured in the left and right eyes at Baseline.

Outcome measures

Outcome measures
Measure	Lumigan® 0.01% n=390 Participants Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
Intraocular Pressure (IOP) at Baseline Right Eye	21.23 Millimeters of Mercury (mmHg) Standard Deviation 4.72
Intraocular Pressure (IOP) at Baseline Left Eye (n=389)	21.38 Millimeters of Mercury (mmHg) Standard Deviation 4.51

PRIMARY outcome

Timeframe: Week 14

Population: All patients with data for this outcome measure

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 14.

Outcome measures

Outcome measures
Measure	Lumigan® 0.01% n=390 Participants Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
IOP at Week 14 Right Eye	15.92 Millimeters of Mercury Standard Deviation 2.71
IOP at Week 14 Left Eye (n=389)	16.05 Millimeters of Mercury Standard Deviation 2.73

SECONDARY outcome

Timeframe: Week 14

Population: All patients with data for this outcome measure

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.

Outcome measures

Outcome measures
Measure	Lumigan® 0.01% n=436 Eyes Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
Physician Evaluation of IOP Lowering in the Study Eye(s) IOP lower than target	83 Eyes
Physician Evaluation of IOP Lowering in the Study Eye(s) Target IOP reached	233 Eyes
Physician Evaluation of IOP Lowering in the Study Eye(s) IOP decreased but target not reached	73 Eyes
Physician Evaluation of IOP Lowering in the Study Eye(s) IOP increased	6 Eyes
Physician Evaluation of IOP Lowering in the Study Eye(s) No change	13 Eyes
Physician Evaluation of IOP Lowering in the Study Eye(s) Data Missing	28 Eyes

SECONDARY outcome

Timeframe: Week 14

Population: All patients with data for this outcome measure

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.

Outcome measures

Outcome measures
Measure	Lumigan® 0.01% n=393 Participants Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
Patient Assessment of Tolerability on a 4-Point Scale Very Good	201 Patients
Patient Assessment of Tolerability on a 4-Point Scale Good	167 Patients
Patient Assessment of Tolerability on a 4-Point Scale Moderate	16 Patients
Patient Assessment of Tolerability on a 4-Point Scale Poor	9 Patients

SECONDARY outcome

Timeframe: Week 14

Population: All patients with data for this outcome measure

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.

Outcome measures

Outcome measures
Measure	Lumigan® 0.01% n=392 Participants Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
Physician Assessment of Tolerability on a 4-Point Scale Very Good	209 Patients
Physician Assessment of Tolerability on a 4-Point Scale Good	171 Patients
Physician Assessment of Tolerability on a 4-Point Scale Moderate	8 Patients
Physician Assessment of Tolerability on a 4-Point Scale Poor	4 Patients

SECONDARY outcome

Timeframe: 14 Weeks

Population: All patients

Patients who discontinued Lumigan® 0.01% prior to 14 weeks was assessed as Yes or No.

Outcome measures

Outcome measures
Measure	Lumigan® 0.01% n=419 Participants Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment	7.9 Percentage of Patients

SECONDARY outcome

Timeframe: Week 14

Population: All patients

Patients who will continue Lumigan® 0.01% after 14 weeks of treatment was assessed as Yes or No.

Outcome measures

Outcome measures
Measure	Lumigan® 0.01% n=419 Participants Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
Percentage of Patients Who Continue Lumigan® 0.01% Treatment	86.2 Percentage of Patients

SECONDARY outcome

Timeframe: Week 14

Population: All patients with data for this outcome measure

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.

Outcome measures

Outcome measures
Measure	Lumigan® 0.01% n=184 Participants Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
Physician Assessment of Patient Compliance Compared to Previous Therapy Better	94 Patients
Physician Assessment of Patient Compliance Compared to Previous Therapy Equal	88 Patients
Physician Assessment of Patient Compliance Compared to Previous Therapy Worse	1 Patients
Physician Assessment of Patient Compliance Compared to Previous Therapy Not Applicable	1 Patients

Adverse Events

Lumigan® 0.01%

Serious events: 0 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lumigan® 0.01% n=419 participants at risk Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
Eye disorders Conjunctival Hyperaemia	8.6% 36/419 All enrolled patients were used to assess adverse events (AEs) and serious adverse events (SAEs).
Eye disorders Eye Irritation	5.0% 21/419 All enrolled patients were used to assess adverse events (AEs) and serious adverse events (SAEs).

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